July 26, 2011 / 7:03 PM / 6 years ago

U.S. FDA advisory meetings through Sept. 20

OBSTETRICS AND GYNECOLOGY DEVICES PANEL

DATE: Sept. 8 and 9, 0800/1200

LOCATION: Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: Shanika Craig, 301-796-6639

The committee will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh used for repair of pelvic organ prolapse. FDA is convening this meeting to seek expert opinion on the risks and benefits of these devices in light of adverse events, e.g., vaginal erosion leading to pelvic pain and dyspareunia, and available information on clinical benefit. The committee will be asked to provide scientific and clinical input on the Agency's proposed premarket and postmarket regulatory strategies for these devices, labeling improvements and postmarket surveillance studies. The committee will also consider surgical mesh used to treat stress urinary incontinence.

JOINT MEETING OF REPRODUCTIVE HEALTH DRUGS AND DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEES

DATE: Sept. 9, 0800/1200

LOCATION: Marriott Inn and Conference Center, University of Maryland University College (UMUC), 3501 University Blvd., Adelphi, Md.

CONTACT: Kalyani Bhatt, 301-796-9001

The committees will discuss the benefits and risks of long-term bisphosphonate use for the treatment and prevention of osteoporosis in light of the emergence of the safety concerns of osteonecrosis of the jaw and atypical femur fractures that may be associated with the long-term use of bisphosphonates. Bisphosphonates for the treatment and prevention of osteoporosis include: FOSAMAX (alendronate sodium) tablets and solution and FOSAMAX PLUS D (alendronate sodium/cholecalciferol) tablets by Merck & Co Inc (MRK.N); ACTONEL (risedronate sodium) tablets, ATELVIA (risedronate sodium) delayed release tablets, and ACTONEL WITH CALCIUM (Copackaged) (risedronate sodium with calcium carbonate) tablets by Warner Chilcott LLC WCRX.O; BONIVA (ibandronate sodium) tablets and injection by Roche Therapeutics Inc ROG.VX; RECLAST (zoledronic acid) injection by Novartis Pharmaceuticals Corp NOVN.VX; and the generic equivalents for these products, if any.

ARTHRITIS ADVISORY COMMITTEE

DATE: Sept. 13, 0800/1200

LOCATION: FDA White Oak Campus, Building 31, Great Room, 10903 New Hampshire Ave., Silver Spring, Md.

CONTACT: Philip Bautista, 301-796-9001

The committee will discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs. The committee will be asked to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs, and whether the risk-benefit balance for these drugs favors continued development of the drugs as analgesics.

ONCOLOGIC DRUGS ADVISORY COMMITTEE

DATE: Sept. 14, 0800/1200

LOCATION: FDA White Oak Campus, Building 31, Great Room, 10903 New Hampshire Ave., Silver Spring, Md.

CONTACT: Caleb Briggs, 301-796-9001

The committee will discuss new drug application (NDA) 021825, with the proposed trade name FERRIPROX (deferiprone) film-coated tablets, application submitted by ApoPharma Inc, represented by CATO Research Ltd. (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with transfusional iron overload (excess iron in the body related to blood transfusions), when current chelation therapy is inadequate.

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

DATE: Sept. 20, 0800/1200

LOCATION: Hilton Hotel, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: Donald Jehn or Denise Royster, 301-827-0314

The committee will meet in open session to hear an overview of the research program in the Laboratory of Enteric and Sexually Transmitted Diseases at the FDA's Center for Biologics Evaluation and Research. The committee will discuss and make recommendations on the safety and immunogenicity of the Pneumococcal 13-valent conjugate vaccine in adults aged 50 years and older using an accelerated approval pathway. (Reporting by Alina Selyukh and Anna Yukhananov; Editing by Tim Dobbyn)

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