U.S. Food and Drug Administration
Office of Special Health Issues
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you are aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, and resources. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
Updates on Fungal Meningitis (Oct 24)
Latest information on the New England Compounding Center (NECC) Meningitis Outbreak
Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems: Class I Recall (Oct 16)
Accutron voluntarily recalled the product after learning through two customer complaints that the flowmeter was flowing nitrous oxide gas without any oxygen gas flow. When not mixed with oxygen, inhaling nitrous oxide can lead to temporary and permanent brain damage and death.
MedWatch Monthly Safety Labeling Changes for September 2012The MedWatch September 2012 Safety Labeling Changes posting include 60 products with safety labeling changes to the following sections: BOXED WARNINGS,CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
For more product safety information, please visit our MedWatch website
FDA approves Fycompa to treat seizures (Oct 22)
FDA approved Fycompa (perampanel) tablets to treat partial onset seizures in patients with epilepsy ages 12 years and older.
FDA expands approved use of Sapien artificial heart valve (Oct 19)
FDA expands the approved indication for the Sapien Transcatheter Heart Valve (THV) to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.
FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes (Oct 18)
FDA approved Jetrea (ocriplasmin), the first drug approved to treat an eye condition called symptomatic vitreomacular adhesion (VMA).
Paclitaxel approved for initial treatment of locally advanced or metastatic non-small lung cancer (NSCLC) (Oct 11)
FDA approved paclitaxel protein-bound particles for injectable suspension, albumin-bound (ABRAXANE for Injectable Suspension) for use in combination with carboplatin for the initial treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for curative surgery or radiation therapy.
For information on drug approvals, please visit our Drugs @ FDA website: http://www.
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
Guidance for Industry - FDA and Industry Actions on Premarket Notification 510(k) Submissions: Effect on FDA Review Clock and GoalsThe Medical Device User Fee Amendments of 20121 (MDUFA III), amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2012, including premarket notification submissions (510(k)s).
Prescription Drug User Fee Act Patient-Focused Drug Development; Request for CommentFDA is announcing a public meeting and an opportunity for public comment related to FDA's patient- focused drug development initiative. This initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Comments due by November 1, 2012
Request for Comment: Open Docket Related to the Drug Safety and Risk Management Advisory Committee, Reclassification of Schedule 3 to 2 of Combination Hydrocodone ProductsThe Drug Safety and Risk Management Advisory Committee will be held on October 29-30, 2012. A docket FDA-2012-N-0548 is open for comments on the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. Comments due by November 6, 2012.
Request for Comments: Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy; Public WorkshopFDA will be holding an open public hearing and workshop to further the understanding of the development of disease-modifying agents for the treatment of painful peripheral neuropathies. Comments for the open public hearing due by February 1, 2013. Written comments due by March 1, 2013.
Unique Device Identification SystemFDA is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Submit either electronic or written comments on the proposed rule by November 7, 2012.
The Value of UDI Implementation for Healthcare Systems and Providers Webinar - November 5, 2012Successful unique device identification (UDI) implementation has the potential to enable a host of benefits for healthcare systems and providers in their operational,financial and clinical activities. To explore this promise of successful UDI implementation, the Engelberg Center for Health Care Reform at the Brookings Institution, in cooperation with FDA and Chickasaw Nation Industries, Inc., will host a webinar on Monday, November 5, from 2:00 PM to 3:30 PM EST.
Dietary supplements, unapproved drugs seized in New York (Oct 23)
At the request of FDA, the U.S. Marshals seized dietary supplements and unapproved drugs from Confidence, Inc.
Prescription Drug User Fee Act Patient-Focused Drug Development Meeting (Oct 25)
FDA is announcing a public meeting and an opportunity for public comment related to FDA's patient-focused drug development initiative. Submit either electronic or written comments by November 1, 2012. The public meeting will be held on October 25, 2012, from 9 a.m. to 12:30 p.m.
Drug Safety and Risk Management Advisory Committee Meeting (Oct 29-30)
The Committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive.
Risk Communication Advisory Committee Meeting (Nov 2)
The Committee will discuss general factors in risk communication about FDA regulated products, including approaches to avoid message fatigue and related communication barriers such as prevention or warning fatigue or inaccurate risk perception.
Anti-Infective Drugs Advisory Committee Meeting (Nov 2)
The committee will discuss raxibacumab injection, a humanized monoclonal antibody against protective antigen of Bacillis anthracis, by Human Genome Sciences, Inc. for the proposed indication of treatment of inhalational anthrax.
Endocrinologic and Metabolic Drugs Advisory Committee Meeting - UPDATED: LOCATION CHANGE (Nov 8):
The committee will discuss Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart), submitted by Novo Nordisk for the treatment of diabetes mellitus. The location for this meeting has changed from the DoubleTree by Hilton Hotel Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Road, Silver Spring, Maryland to FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, Maryland.
Nonprescription Drugs Advisory Committee Meeting (Nov 9)
Discuss MSD Consumer Care, Inc., new drug application for the partial switch from prescription to over-the-counter of the oxybutynin transdermal system for “overactive bladder in women.”
FDA's Clinical Investigator Training Course (Nov 13-15)
FDA’s Center for Drug Evaluation and Research/Office of Medical Policy and the Duke University Office of Continuing Medical Education are cosponsoring a 3-day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. This training course is intended to provide clinical investigators with expertise in the design, conduct, and analysis of clinical trials; improve the quality of clinical trials; and enhance the safety of trial participants.
Anti-Infective Drugs Advisory Committee Meeting (Nov 28)
The Committee will discuss bedquiline, a NME for the treatment of patients with multi-drug resistant tuberculosis (MDR-TB).
Anti-Infective Drugs Advisory Committee Meeting (Nov 29)
The Committee will discuss VIBATIV (telavancin hydrocholoride), a NME for the treatment of hospital-acquired bacterial pneumonia.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting (Dec 4)
The Subcommittee will be discussing issues relating to the development of products for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products under consideration are: (1) Trametinib, application submitted by GlaxoSmithKline, LLC; (2) TH-302, application submitted by Threshold Pharmaceuticals, Inc.; (3) volasertib (BI 6727), application submitted by Boehringer Ingelheim Pharmaceuticals, Inc.; and (4) blinatumomab (MT 103), application submitted by Amgen Inc.
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.
Serious risks associated with using Quinine to prevent or treat nocturnal leg crampsBeginning in 2006, FDA issued a series of warnings not to prescribe the malaria drug quinine (Qualaquin™) for nocturnal leg cramps -- an off-label use -- because it may result in serious and life-threatening hematologic adverse effects.
The New Opioid REMS: The FDA ViewThis new REMS requires that manufacturers make available training for healthcare professionals who prescribe ER/LA opioid analgesics on proper prescribing practices and safe use of these powerful pain medications. Medscape spoke with Gerald J. Dal Pan, MD, MHS, Director of the Office of Surveillance and Epidemiology at the FDA, about this issue.
-Serious risks associated with using Quinine to prevent or treat nocturnal leg cramps (Sept 2012)
FDA BasicsEach month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA.
CDER Director's MailbagHave a question about what the Center for Drug Evaluation and Research (CDER) does? Ask Janet Woodcock, M.D., Director, CDER, FDA
FDA will select some of your questions to answer each month. Due to the volume of e-mails we receive, we won't be able to answer each question in this format. We may edit your questions for brevity or clarity.
Consumer UpdatesTimely and easy-to-read articles covering all FDA activities and regulated products including:
-Decorative Contact Lenses: Is Your Vision Worth It?You can have all of these looks with decorative contact lenses (also called fashion contact lenses or color contact lenses, among other names). These lenses don’t correct vision—they just change the appearance of the eye. Before buying decorative lenses, here’s what you should know
-Scam Alert: Beware of Bogus FDA AgentsSince 2008, hundreds of people who have purchased drugs over the Internet or via telephone have unwittingly exposed themselves to extortion by individuals posing as Food and Drug Administration (FDA) agents.
MedSun Medical Product Safety NetworkThe Medical Product Safety Network (MedSun) improves FDA’s understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The MedSun Web page is a newsletter-based website which provides monthly updates about timely medical device issues that may impact patient safety.
FDA VoiceFDA Voice is the official blog from FDA's senior leadership and staff.
-Commissioner Hamburg: State and Local Partnerships Are Crucial (Oct 24)
When there is a multi-state outbreak of illnesses, what federal agencies are doing in response is often the focus of attention. All too often, the dedicated efforts of countless other public servants at the state, county, and local levels aren’t acknowledged as much.
-CDER Center Director Woodcock: FDA Works with Partners to Establish Important Therapeutic Area Data Standards (Oct 24)
A new partnership between the FDA, the Clinical Data Interchange Standards Consortium (CDISC), and the Critical Path Institute (C-Path) was officially launched today at the CDISC International Interchange in Baltimore.
- National Mammography Day: Supporting Quality Mammography (Oct 19)
Like millions of women, we go each year to get a mammogram. For us the experience is not just about healthy living. It is also a reminder of the value of our hard work at FDA.
Office of Special Health Issues
Food and Drug Administration