PRODUCT SAFETY:
FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate) (Dec 7)
FDA is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate).
CooperVision Avaira Aquaform Sphere Soft Contact Lenses: Class 1 Recall - Unintended Residue on Lenses (Dec 7)
The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Aquaform Sphere contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.
FDA announces changes to risk strategy requirements for 2 drugs to treat low platelet counts (Dec 6)
The approval of changes to the Risk Evaluation and Mitigation Strategies (REMS) for both Nplate (romiplostim) and Promacta (eltrombopag) was announced by FDA.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch
PRODUCT APPROVALS:
FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep (Nov 23)
FDA approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.
For information on drug approvals, please visit Drugs@FDA
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
Request for Nominations for Voting Members on Public Advisory Committee, Science Board to the Food and Drug AdministrationFDA is requesting nominations for voting members to serve on the Science Board to the FDA. FDA has special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups. Nominations received on or before December 28, 2011, will be given first consideration for membership on the Science Board.
Draft Guidance for Industry and Food and Drug Administration Staff; the Content of Investigational Device Exemption and Premarket Approval Applications for Artificial Pancreas Device Systems; AvailabilityThis draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. Comments due by March 5, 2012.
Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies; Availability FDA is announcing the availability of a guidance for industry entitled ‘‘Medication Guides— Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).’’
Comment Request; Approach to Addressing Drug ShortageFDA is opening a comment period in light of public interest in this topic and in order to gain additional insight about the causes and impact of drug shortages, and possible strategies for preventing or mitigating drug shortages. Comments due by December 23, 2011.
ANNOUNCEMENTS:
Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step (Dec 7)
FDA has been carefully evaluating for over a decade whether emergency contraceptives containing levonorgestrel, such as Plan B One-Step, are safe and effective for nonprescription use to reduce the chance of pregnancy after unprotected sexual intercourse.
FDA, FTC act to remove “homeopathic” HCG weight loss products from the market (Dec 6)
FDA and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter HCG products that are labeled as “homeopathic” for weight loss.
- FDA hosted a media teleconference on December 6 to discuss the removal of HCG weight loss products from the market. A replay is available until January 6, 2012 by calling 888-567-0390.
FDA outlines flexible approaches for artificial pancreas system clinical trials, product approvals (Dec 1)
FDA issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.
- FDA hosted a stakeholder teleconference on December 1 to discuss the draft guidance. A replay of the teleconference is available until January 1, 2012 by calling 800-568-6276; passcode 12111.
FDA approves first generic version of cholesterol-lowering drug Lipitor (Nov 30)
FDA approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets).
UPCOMING MEETINGS:
Circulatory System Devices Panel of the Medical Devices Advisory Committee (Dec 7-8)
Joint Meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting (Dec 8)
Joint Meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting (Dec 9)
Psychopharmacologic Drugs Advisory Committee Meeting (Dec 12)
Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee Meeting (Dec 14)--CANCELLED
Antiviral Drugs Advisory Committee Meeting (Dec 14-15)
Public Workshop - The Development and Evaluation of Human Cytomegalovirus Vaccines (Jan 10-11)
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting (Jan 11)
Tobacco Products Scientific Advisory Committee Meeting (Jan 18-20)
Reproductive Health Drugs Advisory Committee Meeting (Jan 20)
Neurological Devices Panel of the Medical Devices Advisory Committee Meeting (Feb 20)
Dermatologic and Ophthalmic Drugs Advisory Committee Meeting (Feb 27)
Public Workshop - Role of Naloxone in Opioid Overdose Fatality Prevention; Request for Comments (Apr 12)
Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.
RESOURCES:
Continuing Education
The Clinical Investigator's CME Program: Transforming a Clinician Into an Investigator: What Does It Take?Panel discussion moderated by Dr. Leonard Sacks, Acting Director, Office of Critical Path Programs at FDA. This CME/CE activity will help clarify the responsibilities of clinical investigators and address some of the challenges that investigators face today.
Articles
Please visit Articles of Interest to access articles produced by FDA and written for a health professional audience. These articles include FDA News for Health Professionals articles, as well as articles that were published in health professional journals.
Videos
LASIK video
LASIK is a surgical procedure intended to reduce a person's dependency on glasses or contact lenses.
MedWatch Safety Information Resources for Busy Physicians A video discussing Medwatch Safety Alerts
