Industry News

 SPA Newsletter   

July 27   New Address for ANDA submissions.   FDA is amending 21 CFR 314.440(a)(2) to update the address for applicants to submit ANDAs and ANDA amendments, supplements, and resubmissions. FDA is also amending 21 CFR 312.140(a)(1) to update the address for ANDA applicants to submit INDs for in vivo bioavailability and bioequivalence studies that are intended to support ANDAs. The new address for all these submissions is: Office of Generic Drugs (HFD–600)                                                                                                             Center for Drug Evaluation and Research                                                                                                             Food and Drug Administration                                                                                                                Metro Park North VII                                                                                                                             7620 Standish Pl.                                                                                                                                          Rockville, MD 20855                                                                               This rule is effective August 1, 2010.  You may find additional information at: http://edocket.access.gpo.gov/2010/pdf/2010-15711.pdf

July 27  Rite Aid Agrees to Pay $1 Million to Settle HIPAA Privacy Case.  Rite Aid Corporation and its 40 affiliated entities (RAC) have agreed to pay $1 million to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, the U.S. Department of Health and Human Services (HHS) announced today. In a coordinated action, RAC also signed a consent order with the Federal Trade Commission (FTC) to settle potential violations of the FTC Act.

Rite Aid, one of the nation’s largest drug store chains, has also agreed to take corrective action to improve policies and procedures to safeguard the privacy of its customers when disposing of identifying information on pill bottle labels and other health information. The settlements apply to all of Rite Aid’s nearly 4,800 retail pharmacies and follow an extensive joint investigation by the HHS Office for Civil Rights (OCR) and the FTC.  These incidents were reported as occurring in a variety of cities across the United States.  Rite Aid pharmacy stores in several of the cities were highlighted in media reports.  Disposing of individuals’ health information in an industrial trash container accessible to unauthorized persons is not compliant with several requirements of the HIPAA Privacy Rule and exposes the individuals’ information to the risk of identity theft and other crimes.  This is the second joint investigation and settlement conducted by OCR and FTC. OCR and FTC settled a similar case involving another national drug store chain in February 2009.

July 22  Federal Government Seizes Cyanide Antidote Kits from California Company.  FDA says Keystone kits are unapproved new drugs, and have not been proven safe and effective.  At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $39,000 worth of products labeled as cyanide antidote kits from Keystone Pharmaceuticals in Laguna Hills, California.  Marketed for use in cases of cyanide poisoning, Keystone distributes the kits primarily to hospitals in the United States and Canada. The products contain a Sodium Thiosulfate injection and a Sodium Nitrite injection in vials, along with components such as needles, tubing, and a syringe.  Most commonly, cyanide exposure occurs through inhaling smoke in residential fires, or through inhaling cyanide fumes during industrial accidents.  The cyanide antidote kits distributed by Keystone are unapproved new drugs under the Federal Food, Drug and Cosmetic Act and are therefore not permitted to be introduced into interstate commerce. The products have not been proven safe and effective for their intended use. 

July 19   ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents   FDA has issued a draft Recommendation for the Revision of the Permitted Daily Exposure for Cumene According to the Maintenance Procedures for Q3C Impurities: Residual Solvents.   It can be found at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM219492.pdf 

July 21   FDA Issues recall on Motrin IB (Ibuprofen) Caplets USP manufactured at McNeil Healthcare’s  Las Piedras, Puerto Rico Facility  Recall of lot #SDA149 (Expiry Date 10/2010) of bottles of 24 coated caplets of Motrin IB (Ibuprofen) Caplets USP, 200mg was issued because product failed dissolution specification.  This comes on the heels of a recall of 21 lots of over-the-counter medicines. The lots involved are sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica. This action is a follow-up to a product recall that McNeil Consumer Healthcare originally announced on January 15, 2010, which was initiated following consumer complaints of a musty or moldy odor, which has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA).   Various Benadryl, Tylenol, and Motrin products are involved.

July 8     Using Quinine Sulfate for Nighttime Leg Cramps Is Risky.  People who use the drug Qualaquin to treat or prevent nighttime leg cramps may be at risk for serious and life-threatening reactions, according to the Food and Drug Administration (FDA).    Qualaquin (quinine sulfate) is FDA-approved only to treat a certain type of malaria (uncomplicated malaria) caused by the parasite Plasmodium falciparum. This infection, which is rare in the United States, is found mainly in travelers who have been to countries where malaria occurs.  However, most of Qualaquin’s use in the U.S. is for the treatment or prevention of nighttime leg cramps—a use not approved by FDA.  FDA has received reports of side effects after people used Qualaquin to prevent or treat leg cramps or restless leg syndrome. Side effects included serious and life-threatening reactions in 38 reports.  Of these 38 reports, there were 24 blood-related reactions, including a severe lowering of platelets in the blood. Some of the blood-related side effects resulted in permanent kidney damage, hospitalization, and two deaths.  Although not mentioned in the FDA report, it has been proposed that in many cases dehydration is responsible for muscle cramps; the nighttime cramps can be minimized by simply drinking a full glass of water just before retiring for the night. 

July 8     More Seniors to Receive One-Time Donut Hole $250 Rebate Checks as a Result of the Affordable Care Act.  The next round of more than 300,000 eligible seniors who have entered the Medicare Part D “donut hole” this year have been mailed their tax-free, one time rebate check for $250.  The first round of checks were distributed in the middle of June. As qualifying Medicare recipients “fall into the donut hole,” they will be sent a rebate check by Medicare.  The donut hole is the period in the prescription drug benefit in which the beneficiary pays 100 percent of the cost of their drugs until they reach the catastrophic coverage phase.

July 6     After 2 Years CDERLearn is Back!  CDER's primary mission is to make certain that safe and effective drugs are available to the American people. There is, however, a strategic initiative to inform and educate people about the safe use of medicine, the drug regulatory process, the vital role health care professionals play to assist FDA in fulfilling its duties, and many other important issues. Online training is one way to share FDA expertise with many more people than face-to-face classroom sessions would allow, and we will offer additional CDER courses in the future.  Full information can be found at:   http://www.fda.gov/Training/ForHealthProfessionals/default.htm                                                                                The Course List:                                                                                                                                            The Past, Present, and Future of FDA Human Drug Regulation                                                          Medicines in my Home – An Interactive Home                                                                                   Bringing an Unapproved Drug into Compliance                                                                                  Risk Assessment and Communication                                                                                                 FDA Medwatch and Patient Safety                                                                                                                Field Investigators: Adverse Drug Effects (ADE) Investigators (2000)                                                 The FDA Process for Approving Generic Drugs                                                                                             An Introduction to the Improved FDA Prescription Drug Labeling                                            

June 28  Bottled Water Everywhere – Keeping it Safe.  Consumers drink billions of gallons of bottled water each year. Find out about FDA's role in ensuring that bottled water products are safe at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm203620.htm  

June 24  Guidance for Industry: CMC Post-approval Manufacturing Changes Reportable in Annual Reports    This guidance can be found as a PDF - 109KB at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM217043.pdf    

June 22 CDER Has Published a List of Key Officials.  The PDF file can be downloaded at:  http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ContactCDER/UCM070722.pdf             

June 22   Magic Power Coffee – Potentially Dangerous, Not Magical!   Consumers should not use an instant coffee being sold online as a dietary supplement for sexual enhancement, warns the Food and Drug Administration (FDA).  The product, Magic Power Coffee, contains a potentially dangerous ingredient. The product is sold in a two-serving box as well as in a carton that contains six two-serving boxes.  The FDA’s lab analysis determined that Magic Power Coffee contains hydroxythiohomosildenafil, a chemical similar to the active ingredient in the prescription drug Viagra to treat erectile dysfunction. The chemical may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. Although Magic Power Coffee is labeled as an “all natural dietary supplement,” it can cause serious harm. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death. 

June 22  FDA Warns About Fraudulent Tamiflu.  Fraudulent product is dangerous to patients allergic to penicillin.  The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as “Generic Tamiflu” sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu’s active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.  The agency reminds patients who are allergic to or may have experienced adverse reactions from penicillin products that they are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse. To date, the FDA is not aware of any reports of adverse reactions.  There is no FDA-approved generic drug for the prescription product Tamiflu.

 June 17  FDA Approves New Treatment for Advanced Prostate Cancer   The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.  In prostate cancer, the male sex hormone testosterone can cause prostate tumors to grow. Drugs, surgery, or other hormones are used to reduce testosterone production or to block it. Some men have hormone refractory prostate cancer, meaning the prostate cancer cells continue to grow, despite testosterone suppression. Different treatments are needed for men with this type of cancer.  Jevtana was reviewed under the FDA’s priority review program, which provides for an expedited six-month review for drugs that may offer major advances in treatment, or provide a treatment when no adequate therapy exists. Jevtana received approval ahead of the product’s Sept. 30, 2010, goal date.  Side effects in those treated with Jevtana included decrease in infection-fighting white blood cells (neutropenia), anemia, decrease in the number of white blood cells (leukopenia), low level of platelets in the blood (thrombocytopenia), diarrhea, fatigue, nausea, vomiting, constipation, weakness (asthenia), and renal failure. 

June 16  Infant Overdose With Liquid Vitamin D   The Food and Drug Administration (FDA) is warning of the potential risk of overdosing infants with liquid vitamin D.  Some liquid vitamin D supplement products on the market come with droppers that could allow parents and caregivers to accidentally give harmful amounts of the vitamin to an infant. These droppers can hold a greater amount of liquid vitamin D than an infant should receive.  Excessive vitamin D can cause nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences like kidney damage.  Infants should not receive more than 400 international units (IUs) of vitamin D a day, which is the daily dose of vitamin D supplement that the American Academy of Pediatrics recommends for breast-fed and partially breast-fed infants.  For more information and recommendations go to:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm214343.htm         

June 9    Public Workshop on Thursday, June 24, 2010 entitled “Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors”  The Food and Drug Administration (FDA) is announcing a public workshop entitled “Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors” to initiate dialogue and share information about the design of drug and therapeutic biologic container labels, carton labeling, and product packaging, and practices to develop testing of proprietary names to reduce medication errors.    It will be held at the Holiday Inn, 10000 Baltimore Ave., College Park, MD 20740 from 8:30am – 4:00pm on Thursday, June 24, 2010, and on Friday, June 25, 2010 from 8:30am – Noon.  Details at: http://www.fda.gov/Drugs/NewsEvents/ucm214703.htm

June 9    Access to Investigational New Drugs   Expanded access, sometimes called “compassionate use” is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternate treatment options.  On Tuesday, February 23, at 3 p.m. ET, the FDA hosted a 30-minute webinar on Access to Investigational Drugs. The featured speakers, Theresa Toigo, Director, Office of Special Health Issues and Richard Klein, HIV/AIDS Program Director, Office of Special Health Issues, discussed factors to consider in deciding whether to seek access to an investigational drug and the ways to access investigational drugs.  You can view the webinar by going to:  http://www.fda.gov/AboutFDA/Basics/ucm200769.htm

June 2    FDA Issues Final Guidance on Statement of Investigator (Form FDA 1572)   FDA has issued final information sheet guidance on "Frequently Asked Questions - Statement of Investigator (Form FDA1572)."   The Guidance is entitled, “Information Sheet Guidance for Sponsors, Clinical Investigators and IRBs, Frequently Asked Questions – Statement of Investigator (Form FDA 1572).  The document is now available from FDA's website using the following web link:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf  

June 1   FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women   The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.  More Info at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm214150.htm  

May 26  FDA Announces Collaboration with Drugs.com   The goal is to expand online distribution of Agency’s consumer health information.  The U.S. Food and Drug Administration announced today that it will collaborate with the Web site Drugs.com to expand access to the FDA’s consumer health information.  Drugs.com seeks to provide patients with information to better manage their own health care and to assist in the reduction of medication errors. It attracts more than 12 million unique visitors each month.

May 26  Weight-Loss Drugs and Risk of Liver Failure   People who take Xenical or Alli need to be aware of the rare occurrence of severe liver injury reported in some individuals who take these weight-loss drugs.  The active ingredient in both of these drugs is orlistat. Xenical (orlistat 120 mg) is a prescription product. Alli (orlistat 60 mg) is sold over-the-counter without a prescription.  What Consumers Should Do - contact your health care professional immediately if you experience itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.  Learn more at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm213401.htm

May 24   No Evidence Linking Cell Phone Use to Risk of Brain Tumors   Do the radio waves that cell phones emit pose a threat to health?  Although research is ongoing, the Food and Drug Administration (FDA) says that available scientific evidence—including World Health Organization (WHO) findings released May 17, 2010—shows no increased health risk due to radiofrequency (RF) energy, a form of electromagnetic radiation that is emitted by cell phones.  FDA also cites a separate National Cancer Institute program finding that, despite the dramatic increase in cell phone use, occurrences of brain cancer did not increase between 1987 and 2005.  FDA shares regulatory responsibilities for cell phones with the Federal Communications Commission.  Although cell phones can be sold without FDA clearance or approval, the agency monitors the effects the phones have on health. FDA has the authority to take action if cell phones are shown to emit RF energy at a level that is hazardous to the user.  Although evidence shows little or no risk of brain tumors for most long-term users of cell phones, FDA says people who want to reduce their RF exposure can:                                                                        

·         reduce the amount of time spent on the cell phone

·         use speaker mode or a headset to place more distance between the head and the cell phone

May 12   Medication Errors from Swallowing Benadryl Extra Strength Itch Stopping Gel   The U.S. Food and Drug Administration (FDA) has received reports of adverse events in consumers who mistakenly swallowed Benadryl Extra Strength Itch Stopping Gel. Although there are over-the-counter liquid Benadryl products intended to be swallowed, Benadryl Extra Strength Itch Stopping Gel is a topical product that is used on the skin. Benadryl Extra Strength Itch Stopping Gel should NOT be swallowed.

Benadryl Extra Strength Itch Stopping Gel is safe and effective when used on the skin as directed. Swallowing it can result in people receiving dangerously large amounts of the active ingredient, diphenhydramine. This can result in serious adverse events, such as unconsciousness, hallucinations, and confusion.  To help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin, the manufacturer, Johnson and Johnson, has taken the following actions:

·         Changed the product label to add a new, prominent statement "For Skin Use Only."

·         Attached a sticker to the cap of the product that says "For Skin Use Only."

·         Initiated consumer studies to better understand factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel.                                                  

FDA encourages manufacturers of similar products to follow Johnson and Johnson's example and adopt similar changes to their labeling and packaging.

May 12   Medical Costs of Cancer Have Nearly Doubled Over the Past Two Decades   A new analysis finds that the costs of treating cancer have nearly doubled over the past two decades and that the shares of these costs that are paid for by private health insurance and Medicaid have increased. The study also reveals that cancer costs have shifted away from inpatient treatments to outpatient care. Published early online in Cancer, a peer-reviewed journal of the American Cancer Society, the information could be used to prioritize future resources for treating and preventing cancer.  The analysis also revealed that the share of total cancer costs incurred after inpatient hospital admissions fell from 64.4 percent in 1987 to 27.5 percent in 2001–2005. The decrease in cancer-related inpatient costs was accompanied by an increase in cancer-attributable outpatient expenditures.

May 10  New CDC Study Finds Colorectal Cancer Screening Practices Need Improvement Current screening methods for fecal occult blood tests often are not appropriate.  More than 75% of primary care physicians in the United States who order or perform the fecal occult blood tests (FOBT) as a screening option for colorectal cancer perform an in-office test rather than relying on the home-based test, even though the home-based test is more accurate, a study by the Centers for Disease Control and Prevention (CDC) has found.  National guidelines recommend that FOBT testing be done with stool samples collected at home. Previous studies have shown that the in-office FOBT, in which a single stool sample is collected by a physician during a digital rectal examination, is ineffective because it misses 95% of cancers or polyps that may become cancer. The in-office test is not recommended for colorectal cancer screening.

May 4   Compliance Program Guidance Manual: 7346.832, Pre-Approval Inspections/Investigations   This information has been updated.  You can download a copy at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM071871.pdf                                        

May 1    McNeil Recalls Infant and Children’s Liquid Products   Working in consultation with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare is implementing a voluntary recall of infant and children’s liquid products due to manufacturing deficiencies which may affect quality, purity or potency.  The products include certain liquid infant’s and children’s Tylenol®, Motrin®, Zyrtec®, and Benadryl® products.  McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. As a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. There are a number of other products on the market, including generic versions of the recalled products, which are intended for use in infants and children and are not affected by the recall. FDA recommends that you check the labeling of these products. If you have any questions, you should discuss this with your pharmacist or other health care professional. FDA does not anticipate that there will be a shortage of alternative products. 

Apr 27    Pharmaceutical Giant Astrazeneca To Pay $520 Million    AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Departments of Justice and Health and Human Services’ Health Care Fraud Enforcement Action Team (HEAT) announced today. Such unapproved uses are also known as “off-label” uses because they are not included in the drug’s FDA approved product label.   Between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness).  These unapproved uses were not medically accepted indications for which the United States and the state Medicaid programs provided coverage for Seroquel.

Apr 19    New contact information for the CDER Small Business Assistance Program                                                        

Center for Drug Evaluation and Research, Office of Communications                                           Division of Drug Information                                                                                                         Brenda Stodart PharmD                                                                                                                      Small Business Assistance                                                                                                                        E-mail: CDERSmallBusiness@fda.hhs.gov                                                                                         10903 New Hampshire Avenue, RM 2286                                                                                                   Silver Spring, MD 20993                                        

                                                                          Phone - (301) 796-3400

Feb 28    CDC H1N1 Flu Website Situation Update FDA   Visits to doctors for influenza-like illness (ILI) nationally decreased this week over last week and remain low. Very few hospitalizations were reported by states during the week ending February 20.

Feb 26    OneTouch SureStep Test Strips (LifeScan) Recall. LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.  More information at:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202254.htm

Feb 1      New Guidance for Industry:                                                                                                                                                                    

•1.      Draft - Adaptive Design Clinical Trials for Drugs and Biologics.   PDF - 424 KB at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf

•2.      Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes.  PDF - 69 KB at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072180.pdf

•3.      Individual Bioequivalence Guidance for Various Drugs.  More at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm

Feb 24    Good Clinical Practice/Human Subject Protection Update.  The Food and Drug Administration is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data involving studies including, but not limited to, clinical investigators, nonclinical laboratory studies, and clinical studies in animals. The proposed rule is now available using the following web link: http://edocket.access.gpo.gov/2010/pdf/2010-3123.pdf  Comments to this proposed rule are due by May 20, 2010.

Feb 24    Warning Letter Close-out Letter for Warning Letters Issued After September 1, 2009.  The FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter.  More info at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Feb 23    Reporting Problems to FDA (video).   View this video to learn how to submit reports of problems to FDA and how the agency uses this information:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm201375.htm  

Feb 22    Orange Book:  The latest version may be found at:  http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

              Orange Book: January 2010: Additions and Deletions to the Drug Product List may be found at:  http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM201486.pdf 

              Current Cumulative Supplement.  PDF - 333KB at:  http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM201486.pdf

Feb 20    Ear Candles: Risk of Serious Injuries.  FDA is notifying consumers and healthcare providers of its warning not to use ear candles - a hollow cone about 10 inches long made from a fabric tube soaked in beeswax, paraffin or a mixture of the two - because they can cause serious injuries, even when used according to the manufacturer's directions. According to advertised claims, a burning ear candle draws ear wax and "impurities" or "toxins" out of the ear canal. Other claims for ear candles include relief from sinus and ear infections, headache and earache, as well as improved hearin, g, "blood purification," improvements in brain function, and cure cancer. FDA has found no valid scientific evidence to support the safety or effectiveness of these devices for any medical claims or benefits. FDA has received reports of burns, perforated eardrums and blockage of the ear canal which required outpatient surgery from the use of ear candles. 

Feb 17    Product Confusion with Maalox Total Relief and Maalox Liquid Products   The U.S. Food and Drug Administration (FDA) has received five reports of serious medication errors involving consumers who used Maalox Total Relief, the upset stomach reliever and anti-diarrheal medication, by mistake, when they had intended to use one of the traditional Maalox liquid antacid products. Maalox Total Relief and the traditional Maalox products are both liquid medications available without a prescription (OTC), but are NOT interchangeable.  These products are intended to treat different medical conditions.

Feb 11    FDA Data Standards Update - SPL Terminology & SPL Starter Package Updates.  The FDA has received numerous complaints concerning their user unfriendly software for registration and listing of drug products.  Requests for a waiver to submit registration and listing on paper are denied unless the company has no access to the internet whatsoever.  Many companies are using electronic content management service companies such as Reed Technology and Information Services, Inc. (http://www.reedtech.com/ ) as a low cost alternative to using their own company staff to file registration and listing information.

The FDA has recently updated their SPL Starter Package: SPL Starter Package 1.4 - (copy and paste into your address bar): http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm

Feb 2      FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain.   The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.  More at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198667.htm

Feb 2      Drug Shortages

•·        Acyclovir    Teva Pharmaceuticals has had manufacturing delays and is planning the following dates for availability:  The 800 mg tablets are planned to be released the week of 2/15.
The 600 mg tablets are planned to be available in early March and the 200mg tablets in early April.
The acyclovir capsules are anticipated to be available soon as well.

•·        Erythromycin Ophthalmic Ointment          Bausch & Lomb is experiencing an increase in demand for this product; they are producing it at a rate consistent with historical use data. 

Feb 1      Key Flu Indicators.  Visits to doctors for influenza-like illness nationally are low.  Overall cumulative hospitalization rates for the 2009-10 influenza season have leveled off in all age groups and very few 2009 H1N1-laboratory confirmed hospitalizations were reported by states during the week ending January 23.  No states reported widespread influenza activity.  Almost all of the influenza viruses identified so far continue to be 2009 H1N1 influenza A viruses and these remain susceptible to the antiviral drugs oseltamivir and zanamivir with rare exception.

Jan 27    New Guidance.

•·        The Food and Drug Administration announced in a Federal Register notice of January 21, 2010, the availability of a guidance entitled ‘‘M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.''   The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources. http://edocket.access.gpo.gov/2010/pdf/2010-1027.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073246.pdf

•·        The Food and Drug Administration announced in a Federal Register notice of January 27, 2010, the availability of a guidance for industry entitled ‘‘The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2-Current Good Manufacturing Practice (CGMP).'' This guidance recommends an alternative method for manufacturers to comply with FDA's CGMP regulations that require laboratory apparatus be calibrated at suitable intervals in accordance with established written specifications.  The guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating U.S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration (MC) tolerances. http://edocket.access.gpo.gov/2010/pdf/2010-1517.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM198649.pdf

•·        The Food and Drug Administration announced in a Federal Register notice of January 27, 2010, the availability of a draft guidance for industry entitled ‘‘Assessment of Abuse Potential of Drugs.'' This draft guidance is intended to assist sponsors who are developing drug and other medical products with the potential for abuse that may need to be scheduled under the Controlled Substances Act. Drugs with abuse potential generally include drugs that affect the central nervous system, drugs that are chemically or pharmacologically similar to other drugs with known abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change. http://edocket.access.gpo.gov/2010/pdf/2010-1516.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM198650.pdf

Jan 27    Inactive Ingredient Data Base Updated. Database provides ability to search for inactive ingredients in approved drug products. http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

Jan 27    Drug Shortages Resolved: Morphine Sulfate Oral Solution  Roxane Laboratories has recently received FDA approval for Morphine Sulfate Oral solution 100mg    per 5ml (20 mg/ml). This is the only FDA approved morphine sulfate oral solution available at this concentration. The firm has sufficient supply to meet the entire market demand and no shortage is anticipated.  Morphine 20mg/5ml and 10mg/5ml remain available as approved products as well.  For the morphine 100mg per 5ml (20mg/ml), there will be a transition period to the new packaging, labeling, and NDC numbers.

Jan 25   Warning: Counterfeit Alli.  The Food and Drug Administration (FDA) is warning the public about a counterfeit version of the weight-loss drug Alli 60 mg capsules (120 count refill pack) being sold over the Internet, particularly at online auction sites.  The counterfeit Alli has                                                           

•·         a missing LOT code on the outer cardboard packaging

•·         an expiration date that includes a MONTH, DAY, and YEAR-the expiration date of the real Alli only contains a MONTH and a YEAR

•·         a plain foil for the inner safety seal without any words on it-the safety seal of the real Alli has the words "SEALED FOR YOUR PROTECTION" prominently printed on it.

•·         large capsules with white powder, as opposed to small white pellets found in the real Alli

•·         a slightly taller plastic bottle with a wider cap and coarser ribbing on the cap than what is seen with the real Alli

Jan 20       New Guidance.  M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (PDF - 295 KB).  Download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073246.pdf

Jan 15       McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the Americas, UAE, and Fiji.   The company is initiating this recall following an investigation of consumer reports of an unusual moldy, musty, or mildew-like odor that, in a small number of cases, was associated with temporary and non-serious gastrointestinal events. These include nausea, stomach pain, vomiting, or diarrhea.   Based on this investigation, McNeil Consumer Healthcare has determined that the reported uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). This can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials.  Learn more at:  http://www.fda.gov/Safety/Recalls/ucm197746.htm

Jan 13       What Vaccines Do You Need (interactive)   More at:  http://www2a.cdc.gov/nip/adultImmSched/   

Jan 13       New Guidance   FDA has issued draft guidance on "IRB Continuing Review after Clinical Investigation Approval."  The guidance document is now available from FDA's website using the following web link:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM197347.pdf.

Jan 11        FDA Approves New Drug for Rheumatoid Arthritis.   The U.S. Food and Drug Administration approved Actemra (tocilizumab) on Friday to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis.  There is a risk for serious adverse side effects.  Learn more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197108.htm   

Jan 7         Structured Product Labeling Training Sessions Announced.  The 2010 Winter/Spring SPL R4 training sessions SPL 101 and Advanced have been scheduled:  http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm155705.htm.   

More training sessions will be scheduled in the future.  

Jan 6         Unique Device Identification Update.  The Global Harmonization Task Force (GHTF) has posted the GHTF Discussion Paper (in view of preparation of a draft guidance on) UDI for Medical Devices.  The title of the paper is "Unique Device Identification (UDI) System".  It can be found at http://www.ghtf.org/ahwg/ahwg-proposed.html   Comments can be sent to entr-cosm-med-dev@ec.europa.eu  .   The deadline for submitting comments is 31 March 2010. 

Dec 30     Information from CDER's Small Business Assistance Bulletin

1)  Newly Added Guidance Documents. This website provides newly added guidance documents issued within the last three months. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm 

                 2)  Orphan Drug Workshops. The FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases. Orphan drugs are either drug or biologic products used to treat conditions affecting fewer than 200,000 people in the United States. Orphan drugs may be already-approved or experimental drugs. The workshops will be held Feb. 25-26, 2010, in Claremont, Calif., and Aug. 3-4, 2010, in Minneapolis. At the workshops, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop. To help participants develop strong applications, FDA staff will provide one-on-one regulatory help. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm195343.htm 

                  3)  FDA/DIA 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making, February 2-4, 2010, 5701 Marinelli Road, Bethesda, MD. More info at:  http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=21509&eventType=Meeting&rpex=N&evtyp=AMTG,MTG&kw=10005&sdt=11-12-2009 

•4)      DIA/FDA CDER/CBER Computational Science Annual Meeting, March 22-23, 2010, Bethesda, MD. Learn more at http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21575&eventType=Meeting  

Dec 30      FDA Warns Public of Continued Extortion Scam by FDA Impersonators.   The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.  The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via "telepharmacies" -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.                                                                         The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, and or incarceration.  "Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment."                                                    FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action, with fines payable to the U.S. Treasury.                                                                                                                                                                                               Anyone receiving a telephone call from a person purporting to be an FDA or other law enforcement official who is seeking money to settle a law enforcement action for the illegal purchase of drugs over the Internet should refuse the demand and call the FDA's Office of Criminal Investigations Metro Washington Field Office at (800) 521-5783 to report the crime.

In addition to posing as FDA officials, criminals have posed as special agents of the DEA, FBI, U.S. Secret Service, U.S. Customs Service, as well as U.S. and Dominican prosecutors and judges. In response, the FDA, in conjunction with various federal, state, and local agencies, is actively pursing criminal charges.                                                                                                                                The FDA also reminds consumers to use caution when purchasing prescription drugs over the telephone or the Internet. In addition to the increased risk of purchasing unsafe and ineffective drugs from Web sites operating outside the law, there is the danger that personal data can be compromised. For more on FDA's concerns about unlawful drug sales on the Internet, see http://www.fda.gov/ForConsumers/ProtectYourself/default.htm.   

Dec 23      Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010

As part of its continuing effort to make the agency more transparent and accessible, the FDA has scheduled a series of workshops abou, t orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases.

Orphan drugs are either drug or biologic products used to treat conditions affecting fewer than 200,000 people in the United States. Orphan drugs may be already-approved or experimental drugs.

The workshops will be held Feb. 25-26, 2010, in Claremont, Calif., and Aug. 3-4, 2010, in Minneapolis. At the workshops, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop. To help participants develop strong applications, FDA staff will provide one-on-one regulatory help.  For more information:

 FDA Orphan Drug Workshops

http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/UCM189586.pdf

Designating an Orphan Product: Drugs and Biologics

http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/default.htm

Dec 23    2009-2010 Influenza Season Week 50 ending December 19, 2009   During week 50 (December 13-19, 2009), influenza activity continued to decrease in the U.S.                                                                                                                                                      

•·         The proportion of deaths attributed to pneumonia and influenza (P&I) was below the epidemic threshold.

•·         Nine influenza-associated pediatric deaths were reported. Eight of these deaths were associated with 2009 influenza A (H1N1) virus infection and one was associated with an influenza A virus for which the subtype was undetermined.

Dec 22      Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions 

Annex 5: Disintegration Test General Chapter (PDF - 32 KB)  Obtain at       http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073427.pdf     

Annex 8: Sterility Test General Chapter (PDF - 32 KB)  Obtain a copy at:      www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm085370.pdf

Dec 18      CDER LEARN Courses Now Being Offered  Learn more at: http://www.fda.gov/Training/ForHealthProfessionals/default.htm

•·         Bringing an Unapproved Drug Into Compliance
The primary audience for this course is manufacturers/distributors of drugs marketed without FDA approval or compliance with an OTC monograph. The secondary audience is health care providers and organizations that establish formularies. Course Time: Approximately 90 minutes

•·         Risk Assessment and Communication
This CME program offered through Discover Health explains ways that physicians can communicate risk to their patients to help them make informed health care decisions. Available for credit through June 27, 2011

•·         FDA Medwatch and Patient Safety
an online tutorial covering the MedWatch program goals of broadcasting safety information and encouraging adverse event reporting

•·         Field Investigators: Adverse Drug Effects (ADE) Investigators (2000)

•·         The FDA Process for Approving Generic Drugs Credit is no longer available for this course.

•·         An Introduction to the Improved FDA Prescription Drug Labeling
The primary audience for this course content is physicians, physician assistants, pharmacists, nurses, nurse practitioners, and dentists. Secondary audiences include other health practitioners who are interested in the revised prescription drug labeling.

Dec 16      Recently issued Guidance for Industry:  Read at:  http://mail.google.com/mail/?shva=1#inbox/1259d539ff3a3fb1 

                  The Guidance are

1)  Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology -Derived Pharmaceuticals

2&3) Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

              Annex 11: Capillary Electrophoresis General Chapter

              Annex 12: Analytical Sieving General Chapter

Dec 16      Other Recently Issued Guidance

1)  Product-Specific Bioequivalence (BE) Recommendations. The Food and Drug Administration announced in a Federal Register notice of December 1, 2009, the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

http://edocket.access.gpo.gov/2009/pdf/E9-28593.pdf   and http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm  

2)  ‘‘Assay Development for Immunogenicity Testing of Therapeutic Proteins.'' The draft guidance provides recommendations to facilitate industry's development of immune assays for assessment of the immunogenicity of therapeutic proteins during clinical trials.

http://edocket.access.gpo.gov/2009/pdf/E9-28960.pdf   and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM192750.pdf  

3)  ‘‘Residual Solvents in Drug Products Marketed in the United States.'' On July 1, 2008, the United States Pharmacopeia (USP) published a new test requirement for the control of residual solvents, General Chapter <467> ‘‘Residual Solvents,'' which replaced USP General Chapter <467> ‘‘Organic Volatile Impurities.'' The change affects all compendial drug products marketed in the United States. This guidance reflects FDA's recommendations on how to comply with those USP changes

http://edocket.access.gpo.gov/2009/pdf/E9-28247.pdf   and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070621.pdf 

Dec 2        Comprehensive List of Guidance Documents for 2009 can be downloaded at: 

                  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079645.pdf  

Dec 2        New/Revised/Withdrawn List of Guidance Documents for 2009 can be downloaded at:

                  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079655.p

Nov 25     CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process; Public Workshop October 15, 2009.   The slides from the presentations at the above Workshop are attached. http://www.fda.gov/Drugs/NewsEvents/ucm182606.htm 

Nov 25      Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Production and Process Controls.   This information can be found at:   http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124782.htm 

Nov 25      New Guidance on Pharmaceutical Development.  This document can be downloaded at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507.pdf 

Nov 23            The FDA has announced the availability of a new Guidance for Industry:  Q8(R2) Pharmaceutical Development.  It can be found at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507 

Nov 20            Vicks Sinex Nasal Spray - Recall   Procter & Gamble and FDA notified consumers of a voluntary recall of three lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom. The bacteria B. cepacia was found in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. Consumers should simply discard the affected product as they would any over the counter medicine. Customers who have the affected lots can call P&G for a replacement coupon or refund.

Nov 20            Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)   FDA Reviews Docket Submissions and Comments from Stakeholder and Public Meetings (Update - November 2009).  FDA is reviewing public and stakeholder input related to the development of a Risk Evaluation and Mitigation Strategy (REMS) for certain opioid drug products.  FDA formed an Opioid REMS Steering Committee, a multidisciplinary team from throughout the Center for Drug Evaluation and Research to carefully review and consider all the input we have received.  This work is divided among eight workgroups that will focus on the following key areas: scope, prescriber education, pharmacist education, patient education, pharmacy systems, patient access to pain medication, metrics and public communication.  FDA recently announced the re-opening of the opioid REMS comment period through October 19, 2010.  

Nov 20            CDC H1N1 (Swine Flu) situation update    Each week CDC analyzes information about influenza disease activity in the United States and publishes findings of key flu indicators in a report called FluView.  During the week of November 8-14, 2009, influenza activity decreased across all key indicators, but overall remained very high for this time of year.

Nov 19            Update of CVM's What's New - Guidance for Industry 191 - New NADAs vs. Category II Supplemental NADAs.  This can be found at: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052460.pdf

Nov 19            FDA Issues 22 Warning Letters to Web site Operators  Part of International Internet Week of Action  The U.S. Food and Drug Administration today completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.  During the effort, the FDA's Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.  The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. "The FDA works in close collaboration with our regulatory and law enforcement counterparts in the United States and throughout the world to protect the public," said FDA Commissioner Margaret A. Hamburg, M.D. "Many U.S. consumers are being misled in the hopes of saving money by purchasing prescription drugs over the Internet from illegal pharmacies. Unfortunately, these drugs are often counterfeit, contaminated, or unapproved products, or contain an inconsistent amount of the active ingredient. Taking these drugs can pose a danger to consumers." 

Nov 17            FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks. The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.  Qutenza contains capsaicin, a compound found in chili peppers. Although there are over-the-counter products with lower concentrations of capsaicin that are marketed for the treatment of PHN, Qutenza is the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo FDA review. It was approved on Nov. 16.   Learn more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191003.htm

Nov 13            FDA to Examine the Safety of Caffeinated Alcoholic Beverages.    On Nov. 13, 2009, the Food and Drug Administration (FDA) sent letters notifying nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.  "The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible," says Joshua Sharfstein, M.D., principal deputy commissioner of food and drugs.  To date, FDA has approved caffeine only as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. The agency has not approved caffeine for use at any level in alcoholic beverages; therefore, these beverages can be lawfully marketed only if their use is subject to a prior sanction or if their use is GRAS.  FDA alerted manufacturers that it is considering whether caffeine can lawfully be added to alcoholic beverages.  In the past year, major brewers Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages (Tilt and Bud Extra, and Sparks) and agreed to not produce any caffeinated alcohol beverages in the future.

Nov 10            FDA Announces Guidance for Industry -  Dosage Delivery Devices for OTC Liquid Drug Products.  This guidance cites examples of dosage cups that may render the product misbranded.  For example, the directions for use specify teaspoon amounts but the cup bears two different graduated scales: teaspoonfuls and tablespoonfuls.  (Editor's note: Apparently, the FDA believes the public can't read.  It this reflective of the current Administration's view of cradle to grave government care?)  You can read the entire document at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM188992.pdf

Nov 9              FDA Approves Drug Treatment for Rare Cancer.   Cutaneous T-cell lymphoma affects about 1,500 Americans annually The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL).   More details at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189629.htm 

Oct 30             Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C.   The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient. 

                        Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against the Cincinnati-based company: 

                        - To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and 

                        - Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.

Oct 29             Investigational Drug Regulations Amended. The Food and Drug Administration announced in a Federal Register notice of October 29, 2009, that the agency is amending its investigational new drug application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for these studies that are intended to support abbreviated new drug applications (ANDAs) should be sent directly to the Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency's regulations.  Details at: http://edocket.access.gpo.gov/2009/pdf/E9-26095.pdf    

Oct 28             SPL Standard for Content of Labeling Technical Qs & As.   The Food and Drug Administration announced in the Federal Register of October 28, 2009, the availability of a draft revised guidance for industry and reviewers entitled ‘‘SPL Standard for Content of Labeling Technical Qs & As.'' This draft guidance is intended to assist sponsors who submit the content of their product labeling to the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) using the Structured Product Labeling standard (SPL) inextensible markup language (XML). The draft guidance also provides information to CDER and CBER staff who review and manage that product information using electronic systems. This draft guidance is being revised to reflect technological changes and changes resulting from the requirement in the Food and Drug Administration Amendments Act of 2007 to submit drug establishment registration and drug listing information electronically.  Go to:  http://edocket.access.gpo.gov/2009/pdf/E9-25940.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072392.pdf 

Oct 26             Guidance for Industry:  Investigator Responsibilities. The Food and Drug Administration announced in a Federal Register notice of October 26, 2009, the availability of a guidance for industry entitled ‘‘Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects.'' This guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The guidance also clarifies FDA's expectations concerning the investigator's responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties. http://edocket.access.gpo.gov/2009/pdf/E9-25629.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf 

Oct 19             Labeling for Human Prescription Drug and Biological Products. The Food and Drug Administration announced in a Federal Register notice of October 19, 2009, the availability of a guidance for industry and review staff entitled ‘‘Labeling for Human Prescription Drug and Biological Products -Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.'' This guidance is intended to provide applicants and review staff with a definition of established pharmacologic class and to help them identify the most appropriate word (term) or phrase that describes the established pharmacologic class for a drug or biological product for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling. This guidance finalizes the draft guidance published in the Federal Register on May 16, 2007. more at : http://edocket.access.gpo.gov/2009/pdf/E9-24991.pdf  and http://www.fda.gov/downloads/Drugs/

Oct 16             Medical Device User Fee Cover Sheet Notice   The FDA is allowing 60 days for public comment in response to this notice. This notice solicits comments on Form FDA 3601 entitled                                                 

``Medical Device User Fee Cover Sheet,'' which must be submitted along with certain medical device product applications, supplements, and fee payment of those applications.  Learn more at: http://edocket.access.gpo.gov/2009/E9-24825.htm 

Oct 16             The Commonwealth of Massachusetts Has Issued Emergency Promulgation of Proposed Amendments Authorizing Administration of Vaccines by Designated Health Care Professionals.  This requires the controversial universal, annual vaccination of healthcare workers and health facility employees.  Read more at: http://www.mass.gov/Eeohhs2/docs/dph/regs/reg_vaccine_phc_memo.pdf  

Oct 16             Questions and Answers about Changes to the USP Heparin Monograph.  The U.S. Food and Drug Administration (FDA) has alerted healthcare professionals to changes in the United States Pharmacopeia (USP) monograph for heparin products, effective October 1, 2009. Heparin manufactured after October 1, 2009 will be approximately 10% less potent than heparin manufactured prior to that date.   More at: http://mail.google.com/mail/?shva=1#inbox/1245cdf84938a52c

Oct 16             US Department of Health and Human Services and the Ad Council Launch National Campaign to Help Prevent The Spread of the H1N1 (Swine Flu) Virus.  Health and Human Services Secretary announced today that the Department of Health and Human Services (HHS) is joining with the Ad Council to launch a series of national television public service advertisements (PSAs) designed to encourage Americans to take steps to protect themselves from the 2009 H1N1 flu virus.  To date millions of Americans have gotten the H1N1 flu virus and more than 600 have died since the spring from H1N1 flu-related complications; including children and pregnant women.   Typically 30,000 die each year from complications from the flu.  More information at:  http://www.hhs.gov/news/press/2009pres/10/20091008d.html

Oct 16             FDA Announces Plans for LASIK Quality of Life Project.   The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.  The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.   Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.  Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.  Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.  "This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure," said Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health.  

Oct 16             FDA: Procter & Gamble Warning Posted in Error.  Yesterday, a warning letter to Procter & Gamble regarding Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C products was posted to the FDA Web site in error. The posting occurred due to an internal systems error, and no warning letter has been sent to Procter & Gamble. The agency regrets any confusion caused by the posting.

Oct 16             The NIOSH Science Blog has been updated: "N-95 Respirators and Surgical Masks.  The emergence of H1N1 has created considerable interest about the use of surgical masks and respirators as infection control measures. Given the recent issuance of revised CDC infection control guidance for healthcare personnel includes recommendations for use of N-95 respirators for the protection of healthcare workers from H1N1 instead of surgical masks.  Read more at:  http://mail.google.com/mail/?shva=1#inbox/12458a6657839d9b

Oct 13             Preparation for ICH meetings in St. Louis, Missouri   The Food and Drug Administration (FDA) is announcing a public meeting entitled "Preparation for ICH meetings in St. Louis, Missouri" to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in St. Louis, Missouri. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in St. Louis, Missouri, October 24-29, 2009, at which discussion of the topics underway and the future of ICH will continue.   Learn how you , can comment at:  http://www.fda.gov/Drugs/NewsEvents/ucm181849.htm

Oct 13                 FDA Acts to Halt Marketing of Unapproved Codeine Sulfate Tablets   The U.S. Food and Drug Administration today warned four companies that they must stop marketing unapproved codeine sulfate tablets. These drugs are opioid analgesics, commonly called narcotics, that are widely used to treat pain.  These particular products have not received FDA approval and the agency has no evidence that they are safe and effective. Another manufacturer, Roxane Laboratories, markets FDA-approved codeine sulfate tablets and is able to meet the demand for the drug. The FDA does not anticipate a supply problem for codeine sulfate tablets.  You can learn more about this warning at:   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186418.htm

Oct 7              HHS Unveils New Features on Flu.gov    Several new resources are now available on the federal government's one-stop resource for flu information -- www.flu.gov . The Web site now features a new H1N1 Self-Evaluation guide for adults 18 and older along with a new Flu Myths and Facts section, which provides the public with the latest and most accurate information about the flu.

Oct 2               Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides the following information on various titles...

Combination Products   The Food and Drug Administration proposed in a Federal Register notice of September 23, 2009, to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for ‘‘single-entity'' and ‘‘co-packaged'' combination products.   More at:  http://edocket.access.gpo.gov/2009/pdf/E9-22850.pdf  

Proprietary Names   The Food and Drug Administration (FDA) announced in a Federal Register notice of October 1, 2009, the opportunity for pharmaceutical firms (applicants) to participate in a voluntary 2-year pilot program for the evaluation of proposed proprietary names to be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The pilot program will enable participating pharmaceutical firms to evaluate proposed proprietary names and submit the data generated from those evaluations to FDA for review, as outlined in the FDA concept paper entitled ‘‘PDUFA Pilot Project Proprietary Name Review.'' This document describes procedures to register and submit data for applicants who wish to have their proposed proprietary names evaluated under the pilot program.   Details at:  http://edocket.access.gpo.gov/2009/pdf/E9-23620.pdf

                        New MaPP   A MaPP (Manual of Policies and Procedures) is a written statement issued by CDER management to prescribe policies, responsibilities or procedures to be applied within CDER in the conduct of its work or daily operations. A recent MaPP was issued by the CDER. This MAPP describes procedures to be used in the Center for Drug Evaluation and Research (CDER) by the Office of Surveillance and Epidemiology (OSE), including the Division of Medication Error Prevention and Analysis (DMEPA), the Office of New Drugs (OND), and the Division of Drug Marketing, Advertising, and Communication (DDMAC) in the Office of Medical Policy for handling requests for proprietary name review.   Learn more at: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM182730.pdf

                        Drug Master Files   Another website that is source of useful information:  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htm

                        Women Small Business Owners   The Small Business Administration has introduced its newest online course for women small business owners, Winning Federal Contracts: A Guide for Women Entrepreneurs.  This training module is free, very comprehensive and includes numerous resources, including many targeted for women-owned businesses.   Sign up at:  http://web.sba.gov/sbtn/registration/index.cfm?CourseId=68

                        Small Business Advocate The Small Business Advocate is a publication of the Small Business Administration. The October issue can be read at:  http://www.sba.gov/advo/oct09.pdf

Oct 1               Guidance for Industry:  Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications    This guidance is available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf

Sept 24           Meetings Announced

                        1)  DIA/FDA Assessing Benefits and Risks of Medicinal Products in Regulatory Decisions, November 3-5, 2009, Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, Maryland. Meeting Information and registration can be found at:  http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=20970&eventType=Meeting

2)  DIA/FDA/PhRMA Modeling and Simulation in Drug Development: Quantitative Approaches for Decision Making, October 28-29, 2009, Marriott Bethesda Pooks Hill, 5151 Pooks Hill Road, Bethesda, Maryland. Meeting Information and registration can be found at: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=20600&eventType=Meeting

Sept 19        Drug Information Update - Public Workshop on Educating the Public About Removal of    Essential Use Designation fo, r Epinephrin, e D.   The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.  The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is holding a public workshop on September 25, 2009 in Rockville, MD to discuss strategies for educating the public about the phase-out of chlorofluorocarbon (CFC)-propelled over-the-counter (OTC) epinephrine inhalers from the US market. The one day workshop will solicit input from key stakeholders in the asthma community, the pharmaceutical industry, experts in health care communication, and the public about how best to alert patients and transition them to therapeutic alternatives.  Read details at:  http://www.fda.gov/Drugs/NewsEvents/ucm180277.htm

Sept 18        Warning on Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Inhalation     Solution.   On September 17, 2009, the U.S. Food and Drug Administration (FDA) advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.  The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.  Details at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm182867.htm  

Sept 16        CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process.  The Food and Drug Administration (FDA) Center for Drug Evaluation and Research      (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug Process to be held October 15, 2009 at FDA's Center for Food Center for Food Safety and Applied Nutrition (CFSAN) at 5100 Paint Branch Parkway, College Park, MD 20740. Auditorium 1A003.  There is no registration fee.  Space is limited to 225 participants. Registration on the day of the event may be possible on a space availability basis.  More info at:  http://www.fda.gov/Drugs/NewsEvents/ucm182606.htm

 Sept 16       FDA Has Announced the Availability of Draft Guidance for Industry:  Microbiological Data for Systemic Antibacterial Drug Products - Development, Analysis, and Presentation.  A copy is available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM182288.pdf     

Sept 15        FDA Clears a Test for Ovarian Cancer That Can Help Identify Potential Malignancies, Guide Surgical Decisions.   The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery.  The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.   OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer.   If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.   OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.   OVA1 uses a blood sample to test for levels of five proteins that change due to ovarian cancer.   The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.  OVA1 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass.   It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer.   Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.  More at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182057.htm

Sept 10        FDA Updates "Warning Letters" Web page.  The U.S. Food and Drug Administration has reorganized and updated the warning letters page in the Inspections, Compliance, Enforcement, and Criminal Investigations section of the FDA Web site. The changes on the Web page are as follows:                                                                                                                         1)  Every Tuesday, the most recently issued warning letters now will be presented under Recently Posted with the date posted.                                                                                    2)  Effective Sept. 1, the Close Out Date is now provided in the Warning Letters table and detailed information about the Warning Letters Close Out Program is provided.                     3) Additional changes include formatting and improved page navigation to help users understand what searching and browsing options are available.                                              The "Warning Letters" page can be found at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm. The FDA will continue to look for ways to improve the "Warning Letters" webpage in the future.

Sept 10        Unexplained Skin Conditions known as "Morgellons".   CDC continues to receive reports of an unexplained skin condition which some refer to as "Morgellons". Persons who suffer from this condition report a range of cutaneous or skin symptoms including crawling, biting and stinging sensations; granules, threads, fibers, or black speck-like materials on or beneath the skin; and/or skin rashes or sores. In addition to skin symptoms, some sufferers also report fatigue, mental confusion, short term memory loss, joint pain, and changes in vision.               At this time, scientists and doctors do not know what causes this condition. They do not know if people who report the condition have common risk factors or if there is a common cause for the symptoms. To assist in learning more about this condition, CDC is conducting an epidemiologic investigation. To learn more about the investigation, please refer to the following link: www.cdc.gov/unexplaineddermopathy/investigation.html  

Sept  9         CDC Awards $22 Million for Colorectal Cancer Screening Program.  CDC has launched the Colorectal Cancer Control Program (CRCCP) by providing funding to 26 states and tribes across the United States. The program supports population-based screening efforts and provides colorectal cancer screening services to low-income men and women aged 50-64 years who are underinsured or uninsured for screening, when no other insurance is available. 

The funding will support screening and diagnostic follow-up care, patient navigation, data collection and tracking, public education and outreach, provider education, and an evaluation to measure the clinical outcomes, costs, and effectiveness of the program. The local programs are expected to begin screening patients for colorectal cancer within six months.

The Colorectal Cancer Control Program can be accessed through CDC's Division of Cancer Prevention and Control Web site: http://www.cdc.gov/cancer/crccp/.

Read the press release announcing the program: http://www.cdc.gov/media/pressrel/2009/r090908.htm .

Sept  9         Controlling Salt in Your Diet.  The FDA has published information to help people control the amount of salt in their diets.  To read, go to:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm181577.htm

Sept  8         Care-Tech Laboratories Agrees to Stop Making, Selling and Distributing Unapproved Antimicrobial Products.  The U.S. Food and Drug Administration today announced that St. Louis-based Care-Tech Laboratories Inc. and its principal officers, John C. Brereton and Sherry L. Brereton, have signed a consent decree, agreeing to stop the illegal manufacture, marketing, and distribution of over-the-counter (OTC) antimicrobial drugs used to treat and prevent infection.  "The FDA is concerned about Care-Tech's products because they lack FDA approval, do not conform to any applicable over-the-counter drug monograph, and are not appropriately manufactured," said Deborah Autor, director of the FDA's Office of Compliance, Center for Drug Evaluation and Research. "Companies have an obligation to consumers to ensure that their products are safe, effective, and high quality, and the FDA recommends that Care-Tech's customers seek alternative products."   More at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm181654.htm  

Sept 3      &nb, sp;   HHS Awards $70.9 Million to States to Expand Health Insurance Coverage.  HHS Secretary Kathleen Sebelius has announced $70.9 million in grants to 13 states to support the expansion of health care coverage for their uninsured populations. The grants are funded under the new State Health Access Program (SHAP), an outgrowth of the agency's State Planning Grant program that operated from 2000-2007.  This program enabled many states to develop innovative plans that increased health insurance coverage for their uninsured residents.   More can be found at:  http://www.hhs.gov/news/press/2009pres/09/20090903c.html

Sept  1         The September 2009 MedSun (Medical Product Safety Network) Newsletter is now available...  It can be found at:  http://mail.google.com/mail/?shva=1#inbox/123774b72eae8c06

Aug  31        A Parents Guide to Kid's Vaccines is now available at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048750.htm

Aug 27         IMPORTANT NOTICE REGARDING REGISTRATION OF IRBs REVIEWING FDA-REGULATED RESEARCH.  If your IRB reviews FDA-regulated research and you have not submitted an initial registration or provided the FDA-specific information required by FDA's new IRB Registration Rule in the modified OHRP database since July 14, 2009, you are not registered with FDA.   If you have not previously registered your IRB in the OHRP database, you may do so using the new IRB registration submission page at http://ohrp.cit.nih.gov/efile/IrbStart.aspx.  If you are updating your information to provide the FDA-specific information, use the electronic submission system page for updating registrations at http://ohrp.cit.nih.gov/efile/IrbRnwStart.aspx.   For further information on FDA's IRB registration requirements contact Jean Toth-Allen, Ph.D., Office of Good Clinical Practice, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, HF-34, Room 16-85, Rockville, MD 20857, telephone (301) 827-1585, e-mail jean.toth-allen@fda.hhs.gov.

Aug  26        Information from CDER's Small Business Assistance-Electronic Drug Establishment Registration and Drug Listing.    The FDA Amendments Act placed into law the requirement for electronic drug establishment registration and drug listing. FDA is adopting the use of extensible markup language (XML) files in a standard SPL format as the standard format for the exchange of drug establishment registration and drug listing information. A series of Structured Product Labeling (SPL) Release training sessions are being offered to individuals responsible for the preparation and submission of drug establishment registration and drug listing information to the FDA. information on these training sessions is provided at this website: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm155705.htm  

In addition to the web conference and face-to-face SPL R4 training sessions, a weekly SPL R4 Q&A/Training session to respond to technical questions related to SPL is being offered to individuals responsible for the preparation and submission of drug establishment registration and drug listing information to the FDA. http://spl-work-group.wikispaces.com/                        For Additional information contact: spl@fda.hhs.gov. 

Aug 25            FDA Authorizes Emergency Use of H1N1 Test for U.S. Troops Serving Overseas.      The U.S. Food and Drug Administration today announced it has issued an Emergency Use Authorization (EUA) that allows a 2009 H1N1 influenza virus test to be used to detect the virus in troops serving overseas.  The EUA allows the U.S. Department of Defense to distribute the H1N1 test to its qualified laboratories that have the required equipment and trained personnel to perform the test and interpret its results.  A EUA authorizes the use of unapproved medical products or unapproved uses of approved medical products during a declared public health emergency.  "The FDA worked quickly with the Defense Department to authorize the use of this test to better protect our troops. The test will aid in more rapid diagnosis of 2009 H1N1 influenza infections so that deployed troops can quickly begin appropriate medical treatment," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.  The U.S. Centers for Disease Control and Prevention (CDC) developed the test, which is called the CDC swH1N1 (swine) Influenza Real-Time RT-PCR.  More details at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm180153.htm

Aug 25         Strategies to Prevent Obesity in the United States.  Learn more about CDC's first comprehensive set of recommended strategies and measures to help communities tackle the problem of obesity through environmental change and policies that promote healthy eating and physical activity at:  http://www.cdc.gov/obesity/data/index.html   In 2008, only one state (Colorado) had a prevalence of obesity less than 20%. Thirty-two states had a prevalence equal to or greater than 25%; six of these states (Alabama, Mississippi, Oklahoma, South Carolina, Tennessee, and West Virginia ) had a prevalence of obesity equal to or greater than 30%.   Blacks had 51 percent higher prevalence of obesity, and Hispanics had 21 percent higher obesity prevalence compared with whites.

Aug 17         Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides assistance to businesses with less than 500 employees in the development of new pharmaceutical products. Through an extensive outreach program SBA provides guidance and information to small pharmaceutical businesses through its ListServ, Q&A's, workshops, and website. The ListServ provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical businesses which includes Federal Register notices, guidance, workshop announcements, etc. The following information is being sent to you via the ListServ

1. Authorized Generic Drugs. The Food and Drug Administration announced in a Federal Register notice of July 28, 2009, the agency is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. The agency is taking this action as part of its implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly.  Refer to: http://edocket.access.gpo.gov/2009/pdf/E9-17963.pdf  

2. New Guidance. The Food and Drug Administration announced in a Federal Register notice of July 30, 2009, the availability of a guidance for industry entitled ‘‘Drug-Induced Liver Injury: Premarketing Clinical Evaluation.'' This guidance is intended to assist the pharmaceutical industry and others engaged in new drug development in the assessment of the potential of a drug to cause severe drug-induced liver injury (DILI) during the conduct of premarketing trials. This guidance defines severe DILI as injury that is fatal or requires liver transplantation.   Go to:  http://edocket.access.gpo.gov/2009/pdf/E9-18135.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf   

3. Rates for Prescription Drug User Fees for Fiscal Year (FY) 2010. The Food and Drug Administration announced in a Federal Register notice of August 3, 2009, the rates for prescription drug user fees for fiscal year (FY) 2010. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Prescription Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA IV, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This notice establishes fee rates for FY 2010 for application fees for an application requiring clinical data ($1,405,500), for an application not requiring clinical data or a supplement requiring clinical data ($702,750), for establishment fees ($457,200), and for product fees ($77,720). These fees are effective on October 1, 2009, and will remain in effect through September 30, 2010. For applications and supplements that are submitted on or after October 1, 2009, the new fee schedule must be used. Invoices for establishment and product fees for FY 2010 will be issued in August 2009, using the new fee schedule. http://edocket.access.gpo.gov/2009/pdf/E9-18457.pdf

4. New Guidance. The Food and Drug Administration announced in a Federal Register notice of August 7, 2009, the availability of a guidance for industry entitled ‘‘Pharmaceutical Components at Risk for Melamine Contamination.'' This guidance provides recommendations that will help pharmaceutical manufacturers of finished products, repackers, other suppliers, and pharmacists who engage in drug compounding to better control their use of at-risk components that might be contaminated with melamine. The guidance explains that the agency is recommending that at-risk components be properly tested for melamine contamination before they are used in the manufacture or preparation of drugs or drug products. http://edocket.access.gpo.gov/2009/pdf/E9-18952.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM175984.pdf

5. Warning Letters. The Food and Drug Administration announced in a Federal Register of August 11, 2009, a program to support public health protection by facilitating the timely issuance of warning letters. The program establishes a timeframe for the submission and agency review of post inspection responses to inspectional observations that are communicated to a firm through issuance of a form FDA 483, list of inspectional observations. The program will begin on September 15, 2009. http://edocket.access.gpo.gov/2009/pdf/E9-19107.pdf

6. Charging Patients for Investigational Drugs. The Food and Drug Administration announced in a Federal Register notice of August 13, 2009, that the agency is amending its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. This final rule revises the charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use and to clarify what costs can be recovered for an investigational drug. This final rule will permit charging for a broader range of uses than was explicitly permitted. This rule is effective October 13, 2009.  Read more at: http://edocket.access.gpo.gov/2009/pdf/E9-19004.pdf  

7. Expanded Access for Treatment Use.  The Food and Drug Administration announced in a Federal Register notice of August 13, 2009, that the agency is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediate size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. This rule is effective October 13, 2009.            ,   Learn more at:  http://edocket.access.gpo.gov/2009/pdf/E9-19005.pdf

8. FDA's Transparency Task Force.  The Food and Drug Administration announced in a Federal Register notice of August 18, 2009, that the agency is reopening until November 6, 2009, the comment period for the notice of public meeting and request for comments that appeared in the Federal Register of June 3, 2009 (74 FR 26712). In the notice of public meeting and request for comments, FDA's Transparency Task Force requested comments on ways in which FDA can make useful and understandable information about FDA activities and decision making more readily available to the public. The agency is taking this action because the agency is planning a second public meeting this fall and is reopening the comment period to allow interested persons additional time to submit comments.  http://edocket.access.gpo.gov/2009/pdf/E9-19778.pdf  

9. Reorganization of the Office of the Commissioner. The Food and Drug Administration announced in a Federal Register notice of August 18, 2009, that the agency has reorganized the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This reorganization includes the realignment of four Deputy-level offices within the Office of the Commissioner: the Office of the Chief Scientist; the Office of Administration (formerly titled the Office of Operations); the Office of Foods; and the Office of Policy, Planning and Budget (formerly titled the Office of Policy, Planning and Preparedness).   http://edocket.access.gpo.gov/2009/pdf/E9-19680.pdf  

10. MaPPs. A MaPP (Manual of Policies and Procedures) is a written statement issued by CDER management to prescribe policies, responsibilities or procedures to be applied within CDER in the conduct of its work or daily operations. A recent MaPP was issued by the CDER. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM174552.pdf

11. The Small Business Advocate. The Small Business Advocate is a publication of the Small Business Administration.  Read at:  http://www.sba.gov/advo/research/sbqei0902.pdf

Aug 17         Keys to Healthy Aging.   What is longevity without health? Adults today are looking not only to extend their lives, but to enjoy their extra years. By 2030, the proportion of the U.S. population aged 65 and older will double to about 71 million older adults, or one in every five Americans. The far-reaching implications of the increasing number of older Americans and their growing diversity will include unprecedented demands on public health, aging services, and the nation's health care system. The Centers for Disease Control and Prevention (CDC) works hard to protect health and promote quality of life through the prevention and control of disease, injury, and disability. CDC has developed some keys to preventing some of the most common health issues facing older adults.  Go To:  http://www.cdc.gov/media/subtopic/matte/pdf/CDCHealthy-Aging.pdf

Jul 16   FDA Approves Opioid Pain Reliever with Required Risk Reduction Plan.  The U.S. Food and Drug Administration today approved Onsolis, medication intended for certain patients with cancer to help manage breakthrough pain - severe flares of pain that break through regular pain medication.

               Onsolis is in a class of drugs that deliver the potent opioid fentanyl through the mouth's mucous membranes. Onsolis delivers fentanyl via an absorbable film that sticks to the inside of the cheek. The drug is indicated for the management of breakthrough pain in patients with cancer, ages 18 and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Such patients are considered opioid tolerant because of their current opioid medication use.

               Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently, r on an as-needed basis. It also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.

Jul 17     What You Should Know About Novel Influenza A H1N1 (Swine Flu).   Novel influenza A H1N1 (swine flu) is a new flu virus of swine origin that was first detected in April, 2009. On June 11, 2009, the World Health Organization (WHO) raised the worldwide pandemic alert level to Phase 6 in response to the ongoing global spread of the novel influenza A (H1N1) virus. A Phase 6 designation indicates that a global pandemic is underway.  You can learn more at:  http://www.cdc.gov/media/subtopic/matte/pdf/CDCNovelH1N1Matte.pdf

Jul 17     Omalizumab (marketed as Xolair): Early Communication about an Ongoing Safety Review.  FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) that suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug.  Xolair is approved for use by adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.  Read the MedWatch safety summary, including a link to the Early Communication about an Ongoing Safety Review, at:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172406.htm

Jul 17     Youth Violence National and State Statistics ~ Monitoring trends in youth violence helps states develop prevention programs and policies that address risk and protective factors.

               To look at youth violence in your state: http://www.cdc.gov/ViolencePrevention/youthviolence/stats_at-a_glance/state_statistics.html  

Jul 17     The following guidances pertaining to Good Clinical Practice are now available:                          1)  Guidance for Industry; Guideline for the Monitoring of Clinical Investigators is at:     http://www.fda.gov/RegulatoryInformation/Guidances/ucm126400.htm.

               2)  The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled `"Development and Use of Risk Minimization Action Plans''. The guidance provides guidance to industry on risk management activities for drug products, including biological drug products, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance addresses the development, implementation, and evaluation of risk minimization action plans for drug products.  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126830.pdf

            3) Guidance  ICH Q9: Quality Risk Management    The purpose of this document is to offer a systematic approach to quality risk management. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, by both regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle. It is not intended to create any new expectations beyond the current regulatory requirements: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073511.pdf   

Jul 15     The following guidances pertaining to Abbreviated New Drug Applications are now available: ANDAs: Impurities in Drug Substances   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172002.pdf         

Jul 15     Nature & Health Co. Issues Voluntary Nationwide Recall of Six Male Enhancement Products Marketed as Dietary Supplements.   Opteron 1 Inc. dba Nature & Health Co., announced today that it is conducting a voluntary nationwide recall of the company's five supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of these five samples found they contains either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED) , its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs.

Jul 15    Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

   Nexium (esomeprazole magnesium) for Delayed Release Oral Suspension:  There was no statistically significant difference between Nexium and placebo in the rate of discontinuation in a multicenter, randomized, double-blind, controlled, treatment-withdrawal study of patients ages 1 to 11 months, inclusive. Patients were enrolled if they had either a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD.

Jul 15     FDA MedWatch - Concentrated Acetaminophen Drops: recall of all lots of 16 oz bulk containers by Brookstone Pharmaceuticals, a cautionary measure to minimize potential risk to patients from dosing errors.   Brookstone Pharmaceuticals and FDA notified healthcare professionals and consumers of a nationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. The recalled drops were manufactured by Pharmaceutical Associates, Inc. This 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations. This aspect of the product coupled with the absence of an integrated dosage delivery device is a contributing factor to possible dosing errors, especially inadvertent overdosing. Over dosage of acetaminophen may result in liver toxicity, kidney damage, and blood disorders. The firm is recalling its product to the consumer level as a cautionary measure to minimize any confusion and potential risk to patients from dosing errors.

Jul 15     Drug Shortages: Methotrexate Injection.   Bedford Laboratories-The following Bedford products are  on backorder with an estimated release date of September 2009.

25mg/ml (2ml) NDC#55390-031-10                                                                                                      25mg/ml (4ml) NDC#55390-032-10
25mg/ml (10ml) NDC#55390-034-10
25mg/ml (8ml) NDC#55390-033-10

Jul 13     FDA announces the availability of the following guidance:

1)   Guidance for Industry:  Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM171672.pdf

2)   Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM171575.pdf

Jul 10     FDA Takes Enforcement Action Against Three New Jersey Dietary Supplement and Protein Powder Manufacturers.   The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees operations at all three companies. The government's complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.  FDA investigators discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.

Jul 10     Inspections, Compliance, Enforcement, and Criminal Investigations - Warning Letters Recently Posted.   Warning letters can be found at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm  

Jul 10     FDA Approves Effient Tablets to Reduce Risk of Heart Attack in Angioplasty Patients.  The U.S. Food and Drug Administration has approved the blood-thinning drug Effient tablets (prasugrel) to reduce the risk of blood clots from forming in patients who undergo angioplasty, a common procedure to unblock a clogged coronary artery.  The fraction of patients who had subsequent non-fatal heart attacks was reduced from 9.1 percent in patients who received Plavix to 7.0 percent in patients who received Effient. While the numbers of deaths and strokes were similar with both drugs, patients with a history of stroke were more likely to have another stroke while taking Effient. In addition, there was a greater risk of significant, sometimes fatal bleeding seen in patients who took Effient. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm171497.htm

Jul 8       The American Recovery and Reinvestment Act. The American Recovery and Reinvestment Act contains a package of loan fee reductions, higher guarantees, new Small Business Administration (SBA) programs, secondary market incentives, and enhancements to current SBA programs that will help unlock credit markets and begin economic recovery for the nation's small business sector. The bill provides $730 million to SBA and makes changes to the agency's lending and investment programs so that they can reach more small businesses that need help.  More information at: http://www.sba.gov/recovery/index.html

Jul 8       Registration and Listing. This guidance document intends to assist persons making regulatory submissions to FDA in electronic format. This guidance is designed to assist manufacturers with electronic submissions of drug establishment registration and drug listing information.  You can read the guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072339.pd

Jul 8       Correction of an OTC Document. The Food and Drug Administration in a Federal Register notice of June 30, announced the agency is correcting a final rule that appeared in the Federal Register of April 29, 2009. The document requires important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal antiinflammatory drugs (NSAIDs). The document was published with an incorrect Analysis of Impacts section and omitted a reference from the reference section of the final rule. The document was also published with an error in the codified text regarding the introductory sentence to the stomach bleeding warning for NSAIDs. This document replaces the incorrect Analysis of Impacts section with the correct Analysis of Impacts section, adds a reference to the reference section of the final rule, and corrects the codified text.  Learn more at: http://edocket.access.gpo.gov/2009/pdf/E9-15403.pdf

Jul 8       Enforcement Report for July 8, 2009.   The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.  http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm170893.htm 

Jul 8      Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs   As part of the cGMP initiative announced in August of 2002, and to help FDA be more transparent with cGMP policy, the FDA has developed this question and answer resource on Current Good Manufacturing Practices. They intend to use this format to provide timely answers to questions about the meaning and application of cGMPs for human, animal, and biological drugs, and to share these widely. These questions and answers generally clarify statements of existing requirements or policy, and as such, are considered Level 2 guidance. This resource is being co-sponsored by CDER, CVM, CBER, and ORA.  Guidance documents represent the Agency's current thinking on a particular subject 21CFR 10.115).   Questions and answers at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124740.htm

Jul 8       Facts About Current Good Manufacturing Practices (cGMPs)  Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American.  Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.  Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives.  You can read these facts at:  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm

Jul 8       Recently Posted FDA Warning Letters   These may be searched and viewed at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Jul 7       FDA Takes Action on Darvon and Other Pain Medications  The Food and Drug Administration (FDA) announced actions it was taking to reduce the risk of overdose in people who use pain medications, such as Darvon and Darvocet. These medications contain the drug propoxyphene, which is linked to death from overdoses.  FDA finds there is evidence that propoxyphene can effectively treat pain at recommended doses. But because of the drug's potential risks, the agency is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain treatment.  The FDA's actions include:

FDA is requiring manufacturers of propoxyphene-containing products to strengthen the label's boxed warning to emphasize the risk for overdose when using these products.

FDA is requiring manufacturers to provide a medication guide (FDA-approved information that must be given to patients with each prescription or refill) to stress the importance of using the pain drugs only as directed.

FDA is requiring a new safety study to find out more about the effects of propoxyphene on the heart at higher than recommended doses.

FDA is planning to work with other federal agencies, such as the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs, to conduct additional studies on the safety of products that contain propoxyphene as compared to other commonly used pain medications.

FDA has denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene.

FDA will further evaluate the safety of propoxyphene and take additional regulatory action, if necessary.

 More information is available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm171714.htm

Jul 7       The Division of Drug Information (DDI) is now on Twitter. The DDI is CDER's focal point for public inquiries. It serves the public by providing information on human drug products and drug product regulation by FDA. DDI has recently joined Twitter. For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter:  http://twitter.com/fda_drug_info.

Jul 7       FDA Warns Not to Consume Two Liquid "Energy" Products.  The Food and Drug Administration (FDA) has warned consumers not to buy or use two liquid products that have been recalled due to suspected product tampering.

The products are

•·                     New Whey liquid products

•·                     Hardcore Energize Bullet liquid products

The products are sold in vials that look similar to test tubes. 

The suspected tampering involved a utility knife blade found in one vial of Hardcore Energize Bullet drink and another blade in one vial of New Whey liquid products. No one is known to have been hurt.   Details can be found at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm170631.htm

Jul 6       Pediatric Exclusivity Granted.   A list to which FDA has granted pediatric exclusivity for pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act can be found at:  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050005.htm

Jul 1      Are Green Jobs Good for Workers?  Green jobs-good for the environment, good for the economy. But are green jobs good for workers? The National Institute for Occupational Safety and Health (NIOSH) and its partners recently launched the "Going Green: Safe and Healthy Jobs Initiative" to make sure that green jobs are good for workers by integrating worker safety and health into "green jobs" and environmental sustainability.  More at: http://www.cdc.gov/niosh/blog/

Jun 30    FDA Seeks Public Input on Tobacco Regulation  The U.S. Food and Drug Administration announced today that it is seeking public input on the implementation of its historic new authority overseeing tobacco products in the United States. In a Federal Register notice, the agency invites the public to provide information and share views on a wide range of topics, from product content to advertising and marketing. All public comments will be posted online.  The Federal Register notice can be viewed at: http://edocket.access.gpo.gov/2009/pdf/E9-15549.pdf.

Jun 27   Quinine Sulfate (Marketed as Qualaquin): Off-Label Use.  Quinine sulfate is approved by the FDA for treatment of uncomplicated Plasmodium falciparum malaria, a rare disease in the United States. Drug use data indicate that many prescriptions for quinine sulfate are written in this country, most likely for off-label uses (e.g., the treatment of nocturnal leg cramps). Despite taking several regulatory actions to ensure the safe use of quinine, FDA continues to receive reports of serious adverse events associated with this drug. From April 2005 through October 1, 2008, 38 domestic cases with serious outcomes were reported to FDA's Adverse Event Reporting System (AERS). Most reports were of hematologic events, including cases of thrombocytopenia, and resulted in the hospitalization of the patient. Practitioners should be aware that there are no data indicating that quinine is effective for the treatment of nocturnal leg cramps or other musculoskeletal disorders, and given the potential for life-threatening adverse events, should use extreme caution in off-label prescribing.  To learn more go to:
http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/ucm167883.htm#QuinineSulfateMarketedasQualaquin:Off-LabelNotApprovedbyFDAUseofQuinine 

Jul 6       FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer.  The U.S. Food and Drug Administration has approved Alimta (pemetrexed), the first drug available for maintenance therapy of advanced or metastatic lung cancer.  Patients with cancer often receive maintenance therapy to prevent the disease from progressing after their tumor has shrunk or the disease has stabilized in response to chemotherapy. Alimta disrupts metabolic processes that are dependent on the B-vitamin folate, a necessary ingredient fo, r cell replication.  To learn more, visit:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170515.htm

Jul 2       Chantix and Zyban, Smoking Cessation Drugs, to Get Boxed Warning on Serious Mental Health Events.   On July 1, 2009, the U.S. Food and Drug Administration (FDA) announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (buproprion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.  Health care professionals who prescribe Chantix and Zyban should monitor patients for any unusual changes in mood or behavior after starting these drugs. Patients should immediately contact their health care professional if they experience such changes.  Details at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm170356.htm 

Jun 24    FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under.   The U.S. Food and Drug Administration today approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under.  

Plan B was first approved in 1999 for prescription use only for women of all ages. Plan B is manufactured by Duramed Pharmaceuticals Inc., of Cincinnati.

In 2006, Plan B was approved for nonprescription use for women ages 18 and older. Plan B remained available as a prescription-only product for women ages 17 and under. Today's approval allows marketing of a prescription-only generic product for women ages 17 and under. No generic levonorgestrel product for emergency contraception can be approved for nonprescription use in women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity held by Duramed for the nonprescription use expires.

The generic levonorgestrel tablets 0.75 mg are made by Watson Laboratories Inc., based in Corona, Calif. 

Details at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168870.htm

Jun 17    MedWatch - Cefepime: FDA determined that data review do not indicate a higher rate of death in cefepime-treated patients.  FDA notified healthcare professionals that it has finished its analysis of a possible risk of higher death with cefepime, an antibiotic, following publication of a study that suggested a higher rate of death in patients treated with this drug, as compared to patients treated with similar drugs. FDA reviewed this study data and conducted additional analyses based on additional data, including data submitted by Bristol Meyers Squibb. FDA has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Cefepime remains an appropriate therapy for its approved indications. FDA will continue to review the safety of cefepime. As part of this ongoing review, both FDA and Bristol Meyers Squib are conducting separate analyses of death potentially associated with cefepime.  More info at: http://mail.google.com/mail/?shva=1#inbox/121eef6c924ca122  

Jun 16    Hi-Tech Pharmaceuticals, Inc. Issues Nationwide Recall of All Lots of Stamina-Rx Dietary Supplement Products.   On May 1, 2009, Hi-Tech was notified by the Food and Drug Administration (FDA) that FDA's lab analysis of one lot of Stamina-Rx samples found that the product contained the undeclared ingredient - benzamidenafil - a Phosphodiesterase Type 5 (PDE5) inhibitor. The lot number found to contain benzamidenafil is Lot 08141578, Exp. 9/10. Benzamidenafil is in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED).   More can be read at: http://www.fda.gov/Safety/Recalls/ucm167139.htm

Jun 16    Process Begins to Define "Meaningful Use" of Electronic Health Records.  The Recovery Act provides Medicare and Medicaid incentive payments to eligible providers, such as physicians and hospitals, in order to increase the adoption of electronic health records (EHRs). To receive the incentive payments, providers must demonstrate "meaningful use" of a certified EHR. Building upon the work done by the HIT Policy Committee, the Centers for Medicare & Medicaid Services (CMS), along with the Office of the National Coordinator for Health Information Technology (ONC), will be developing a proposed rule that provides greater detail on the incentive program and proposes a definition of meaningful use. CMS expects to issue the proposed rule in late 2009, which will be followed by a comment period.  More information is available at: http://www.hhs.gov/news/press/2009pres/06/20090616a.html

Jun 16    FDA Advises Consumers Not To Use Certain Zicam Cold Remedies.  The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

The products are:                                                                                                                                 Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21) (a discontinued product)                        More detail at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm

Jun 15     MedWatch - Stimulant Medication in Children with AD/HD - FDA perspective on study data published about potential risks of AD/HD Simulant Medications. Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.  This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident. The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study's methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child's stimulant medication.  Read the complete MedWatch 2009 Safety Summary, including a link to the Communication and the FDA News Release, at:                                                                        http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166667.htm

Jun 13    FDA Issues Public Health Advisory Regarding Levemir Insulin.  The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.  More at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm166358.htm

Jun 11    FDA Approves Injectable Form of Ibuprofen.   The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.

"Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options," said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA's Center for Drug Evaluation and Research. "But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products."

               Caldolor will be available for hospital use only.

               More info at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm165971.htm                 

Jun 10   New and Improved FDA Website.    Recently FDA has launched their new and improved website with an updated look and better searchability.  All offices within the FDA have had their websites incorporated under the main FDA webpage.   The FDA studio now has two websites - one for internal programming to FDA employees and one for external programming for both FDA employees and any outside organizations and industry to watch.  Please note that the internal site is only accessible to FDA.  External site:  http://www.fda.gov/AboutFDA/CentersOffices/CDRH/DivisionofCommunicationMediaFDATVStudio/default.htm 

  Jun 10  Recalls  More information can be found at:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=87#1

               Raptiva Withdrawn from the Market    Prescribers should work with patients to transition to alternative psoriasis therapies.  Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by the JC virus, is a rapidly progressive and irreversible infection of the central nervous system that leads to death or severe disability. Although the overall risk of PML for patients on Raptiva is low, it appears to be increased in long-term users of the drug and in those with compromised immune systems.

               Recalls of Digoxin and Propafenone Tablets   Cardiac drugs recalled because of a possible variation in tablet size.  FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets:

Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin tablets. Included in the recall are 0.125 and 0.25 mg tablets that were distributed prior to March 31, 2009 and which show an expiration date of September, 2011.

Because of the variation in tablet size, these products could contain either more or less than the labeled amount of digoxin. Digoxin has a narrow therapeutic index, which means that small variations in tablet potency could have serious effects. Too much of the drug can cause digoxin toxicity, which can include hypotension and cardiac instability and may lead to death. Too little can lessen the drug's effectiveness, which can also lead to cardiac instability.

Watson Pharmaceuticals recalled one lot of 225 mg propafenone HCL tablets, packaged in bottles of 100, because they may contain slightly more than the labeled amount of the drug. The recalled tablets show an expiration date of July 31, 2010. Like digoxin, propafenone has a narrow therapeutic index, and too much of the drug can cause hypotension and arrhythmias.

Patients and providers should report problems they encounter with any of these recalled products to FDA's MedWatch program.

               Recall of Zencore Plus   Consumers taking organic nitrates who also took Zencore Plus may experience a sudden and profound drop in blood pressure.  Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as sildenafil, tadalafil, and vardenafil, which have been approved by FDA for the treatment of erectile dysfunction.

A person taking organic nitrates who also took Zencore Plus could experience a sudden and profound drop in blood pressure, which would pose a significant health risk.

Zencore Plus capsules, which were supplied by Hi-Tech Pharmaceuticals, have been sold in health food stores, by mail order and on the internet. People who have this product should stop using it immediately.

Jun 10   Warning Letters.  Recent Warning Letters may be found at  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Jun 9     HHS Secretary Sebelius Releases New Report on Health Disparities - Minorities, Low Income      Americans More Likely to Be Sick, Less Likely to Get Care  U.S. Health and Human Services (HHS) Secretary Kathleen Sebelius today released a new report on health disparities in America and participated in a White House Health Care Stakeholder Discussion on the importance of reform that reduces disparities that exist in our current health care system. The new report Health Disparities: A Case for Closing the Gap is available at http://www.healthreform.gov/ .                          

               Under the status quo:

•·               Forty-eight percent of all African Americans adults suffer from a chronic disease compared to         39 percent of the general population.

•·               Eight percent of white Americans develop diabetes while 15 percent of African Americans, 14 percent of Hispanics, and 18 percent of American Indians develop diabetes.

•·               Hispanics were one-third less likely to be counseled on obesity than were whites -- only 44 percent of Hispanics received counseling.

•·               African Americans are 15 percent more likely to be obese than whites.

Jun 9    Skin Products Made by Clarcon being recalled  FDA notified consumers and healthcare professionals that Clarcon Biological Chemistry Laboratory is recalling some skin sanitizers and skin protectants because of high levels of disease-causing bacteria found in the product. During an FDA inspection, analyses of samples of several of these products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage. These findings are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases. FDA is warning consumers to not use any Clarcon products and should throw these products away in household refuse. Read the complete MedWatch 2009 Safety summary, including a link to the FDA News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm165028.htm

Jun 8     California Man Sentenced for Prescription Drug Diversion  CONCORD, NEW HAMPSHIRE: Thomas Lavery, of Irvine, CA, was sentenced to 52 months of incarceration to be followed by three years of supervised release for illegally distributing large quantities of Serostim, an HIV drug, which were illegally purchased from illegitimate sources and then illegally sold to wholesale distributors in various parts of the country, using falsified paperwork. Judge McAuliffe also entered an order of forfeiture against Lavery for the sum of $1,009,460.

Jun  8     FDA Reposts Its Requirement For Boxed Warning for All Botulinum Toxin Products.  Prompted by reports of serious adverse events, the U.S. Food and Drug Administration on April 30  announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products.                                  The agency said it took the action because of reports that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.                                                                       These symptoms have mostly been reported in children with cerebral palsy being treated with the products for muscle spasticity, an unapproved use of the drugs. Symptoms have also been reported in adults treated both for approved and unapproved uses.                                                      The agency also took the action because of the potential for serious risks associated with the lack of interchangeability among the three licensed botulinum toxin products.  The products required to add the new label and a REMS are Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan; Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences; and a new FDA-approved product, Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm Ltd.         You can learn more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149574.htm

Jun 8      Final Product-Specific Bioequivalence (BE) Recommendations. The Food and Drug Administration announced in a Federal Register notice of June 8, 2009, the availability of final product-specific bioequivalence (BE) recommendations. The recommendations provide products specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products'' explaining the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. http://edocket.access.gpo.gov/2009/pdf/E9-13261.pdf

Jun 5     Flu Weekly Report and Flu Weekly Map for Centers for Disease Control and Prevention (CDC). This information is updated frequently and is now available at http://www.cdc.gov/flu/weekly/  and  http://www.cdc.gov/flu/weekly/usmap.htm

Jun 4     The FDA Data Standards Council's SPL web page was updated Thursday, June 4, 2009, to provide the following updates:

Session 14 - June 19, 2009, Web Conference 9:00 - 10:30 a.m. - SPL R4 Training - Preparing Bulk Ingredient/Bulk Product Electronic Drug Listing Submissions

Session 15 - June 26, 2009, Web Conference 9:00 - 10:30 a.m. - SPL R4 Training - Preparing OTC Drug Product Electronic Drug Listing Submissions

See this web page for more details:  http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm155705.htm

Jun 3      FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug  The U.S. Food and Drug Administration today warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil for the treatment of Graves' disease.  "After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA's Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If propylthiouracil therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."   Propylthiouracil was approved for marketing in 1947.  More information at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm164207.htm

Jun  3  The Food and Drug Administration announced in a Federal Register notice of June 3, 2009, the availability of a draft guidance for industry and researchers entitled ‘‘The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application.''   This draft guidance provides information to those using radioactive drugs for certain research purposes to help determine whether research studies may be conducted under an FDA-approved radioactive drug research committee, or whether research studies must be conducted under an investigational new drug application(IND). It also offers answers to frequently asked questions on conducting research with radioactive drugs, and provides information on the membership, functions, and reporting requirements of a radioactive drug research committee approved by FDA. http://edocket.access.gpo.gov/2009/pdf/E9-12832.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM163892.pdf   

Jun 2     FDA is announcing the formation of a Transparency Task Force to recommend ways to  improve the openness and transparency of the agency's information. This will help make useful and understandable information about FDA activities and decision making more readily available.   Carrying out the task force's recommendations should make agency actions, decisions, and underlying processes more transparent to the public, while still meeting the agency's goal of appropriately protecting confidential information. Further, carrying out the recommendations should also reduce the need for requests by the public for agency information under the Freedom of Information Act (FOIA).   More information is at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm163900.htm 

Jun 2      Guidance Documents   Guidance documents represent FDA's current thinking on a topic.  They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.  If you believe an FDA employee is not following FDA's Good Guidance Practice regulations (21 CFR 10.115) or the Office of Management and Budget's Bulletin No. 07-02(M-07-07) Final Bulletin for Agency Good Guidance Practices (January 18, 2007),  you should contact the employee's supervisor in the issuing office or Center.  If the issue is not resolved, contact the next highest supervisor or the Center's Ombudsman.  If the issue is still not resolved, contact the FDA's Office of the Ombudsman at:                                                          FDA Office of the Ombudsman
5600 Fishers Lane, Rm. 13B-07  
Rockville, MD 20857
Phone:                 301-827-3390        
Fax:  301-480-8039
Email:  Ombuds@oc.fda.gov

Jun 1     The Food and Drug Administration announced in a Federal Register notice of June 1, 2009, the availability of a guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing.'' This guidance document is designed to assist industry (e.g.,manufacturers, repackers, and relabelers) with the electronic submission of drug establishment registration and drug listing information. Specifically, the document provides guidance to industry on the types of information to include for purposes of drug establishment registration and drug listing and on how to prepare and submit the information in an electronic format that FDA can process, review, and archive. http://edocket.access.gpo.gov/2009/pdf/E9-12743.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072339.pdf     

May 27  The Food and Drug Administration announced in a Federal Register notice of May 27, 2008, the availability of a draft guidance for industry entitled ``Presenting Risk Information in Prescription Drug and Medical Device Promotion.'' This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and device promotional pieces to determine whether they adequately present risk information. The guidance describes and discusses the factors FDA considers when evaluating prescription drug advertisements (ads), restricted device ads, and prescription drug and device promotional labeling for their compliance with the Federal Food, Drug, and Cosmetic Act (the act) and relevant regulations. The guidance gives examples to illustrate FDA's thinking on these factors and is intended to help regulated industry gain a better understanding of what they should consider as they develop the content and format of their promotional communications. http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-12255.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf

May 27  FDA Announces Minor Use/Minor Species (MUMS) Grant Program  The Food and Drug Administration today announced the initiation of a grant program to support the development of new animal drugs intended for minor species or minor uses in major species. (Major species are horses, dogs, cats, cattle, pigs, turkeys and chickens.)

The implementing regulations for Designation were finalized in July 2007, and Congress appropriated money to support the program in March of this year.                                                 FDA now has $750,000 to offer in MUMS grants for the fiscal year ending September 30, 2009.  You can read more at:  http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm161627.htm

May 19   Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants is available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM153222.pdf

May 19   Final Rule to Require Organ Specific Warnings. The Food and Drug Administration announced in a Federal Register notice of April 29, 2009, a final rule to require important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA). http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-9684.pdf

May 19   Deaths - Final Data for 2006  The age-adjusted death rate in 2006 was a record low. The death rates for males declined between 2005 and 2006 for age groups 1-4 years, 5-14 years, 35-44 years, 45-54 years, 55-64 years, 65-74 years, 75-84 years, and 85 years and over. The largest statistically significant decrease for males occurred among those aged 1-4 years (8.7 percent). The only statistically significant increase (2.4 percent) in the age-specific death rate among males occurred for those aged 25-34 years.   http://www.cdc.gov/nchs/data/nvsr/nvsr57/nvsr57_14.pdf

May 19   Current Drug Shortages: Morphine Sulfate Oral Solution, Roxane- has product available. See information in Related Information section, Mallinckrodt- Increased demand due to another manufacturer leaving the market, Lannett-Increased demand due to another manufacturer leaving the market, and Glenmark- Increased demand due to another manufacturer leaving the market. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

May 18   MedWatch April 2009 Safety Labeling Changes - 65 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions      The April 2009 posting includes 65 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.                                                                            The following 45 drugs had modifications to the BOXED WARNING, CONTRA, INDICATIONS, and WARNINGS sections:   Extraneal, Remicade, Orap, Prevpac, Soma Compund, Aleve, Aleve Liquid Gels, Aleve-D Sinus & Cold, Axert, Carbatrol, Celontin, Depakene, Depakote, Depakote ER, Depakote Sprinkle, Depo-Medrol, Dilantin, Doribax, Enlon Plus, Equetro, Exjade, Felbatol, Gabitril, Heparin Solium injection, Ibuprofen, Kaletra, Keppra/Keppra XR, Klonipin, Lamictal, Lyrica, Midol, Motrin, Children's Motrin Cold, Mysoline, Neurontin, Peganone, Sarafem, Stavzor, Tarceva, Tegretol, Topamax, Tranxene, Treanda, Tridione, Trileptal, Zarontin, Zonegran                                        The "Summary Page" provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/safety/2009/apr09_quickview.htm                                                     The "Detailed View Page" identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/safety/2009/apr09.htm

May 15   CDC Travel Health Warning for Novel H1N1 Flu in Mexico Removed  CDC's Travel Health Warning recommending against non-essential travel to Mexico, in effect since April 27, 2009, has now been downgraded to a Travel Health Precaution for Mexico.  http://wwwn.cdc.gov/travel/content/travel-health-precaution/novel-h1n1-flu-mexico.aspx

May 15   New Labeling Required for OTC Pain and Fever Medicines  On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling.   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149573.htm

May 15   Resolved Drug Shortages - Fentanyl Transdermal Patch http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050793.htm

May 14   Drug Shortages - Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg)     http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050793.htm

May 11   AS Medications Solution LLC. Announces a Nationwide Recall of All Lots of Digoxin Tablets 0.25mg Due to Size Variability  A S Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin.   http://www.fda.gov/Safety/Recalls/default.htm

May 11   FDA Alerts Consumers to Recall of Water-Based Face Paints  Fun Express, Inc. recalls children's face paint associated with adverse events.   The Food and Drug Administration is advising consumers to stop using certain cosmetic "Face Paint" items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children. These items were distributed nationwide.   The FDA has learned of a cluster of adverse events in children exposed to various colors of the face paint. All exposures occurred on the same day at an organized event and included rashes, itchiness, burning sensation, and swelling where the face paints were applied. Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory.   The following Face Paints manufactured by Shanghai Color Art Stationery Company Limited, Shanghai, China, are being voluntarily recalled by Fun Express Inc., a wholly-owned subsidiary of Oriental Trading Co.  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm152301.htm

May 11   Dietary Supplements Worth $1.3 Million Condemned and Forfeited to the United States Under Consent Decree At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Mich. The seized products were marketed for use by body builders and distributed on the Internet and in retail stores under the names Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL.   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm152358.htm

May 8     FDA Approves Drug for Treatment of Aggressive Brain Cancer.  The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm152295.htm

May 7     Safety Concerns for Testosterone Gel   Side effects in children prompt additional warnings on testosterone gel products for adults.  The U.S. Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products' labels. The agency is requiring this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).  In most of the cases, users of these products failed to follow appropriate use instructions, resulting in direct contact between treated skin and the child.  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149580.htm

May 1     The FDA is warning consumers to immediately stop using Hydroxycut products.  These products are manufactured by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.  Hydroxycut products are dietary supplements that are marketed for weight loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.   http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm152152.htm

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