Peripheral and Central Nervous System Drugs Advisory Committee

Peripheral and Central Nervous System Drugs Advisory Committee
Meeting on October 17, 2011, from 8 a.m. to 5 p.m.

Agenda: On October 17, 2011, the committee will discuss supplemental new drug application (sNDA) 21641 (013) for AZILECT (rasagiline mesylate) Tablets, manufactured by Teva Neuroscience, Inc., for the following proposed indication: Treatment of patients with idiopathic (of unknown cause) Parkinson’s disease to slow clinical progression and treat the signs and symptoms of Parkinson’s disease as initial monotherapy (the single drug used to treat) and as adjunct (additional) therapy to levodopa.

Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee
Meeting on September 14, 2011, from 8 a.m. to 5 p.m.

Agenda: On September 14, 2011, during the morning session, the committee will discuss new drug application 021825, with the proposed trade name Ferriprox (deferiprone) filmcoated 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. (Chelation therapy in these patients binds iron in a form that allows it to be eliminated from the body).
During the afternoon session, the committee will consider the development of products for the treatment of patients with nonmetastatic castration resistant prostate cancer (CRPC) who have a rising serum level of prostate-specific antigen (PSA) despite being on androgen deprivation therapy (ADT). There are no products currently approved for this indication. No specific products will be presented or discussed; rather, the committee will be asked to consider possible trial designs and suitable clinical endpoints to establish efficacy that would support a labeled indication for treatment of nonmetastatic CRPC after PSA progression on ADT. Because ADT is an unproven therapy for this condition with serious long-term toxicity, the committee will be asked whether approval of a new therapy in conjunction with continued ADT would be appropriate for patients with non-metastatic CRPC.

Vaccines and Related Biological Products Advisory Committee

Vaccines and Related Biological Products Advisory Committee
Meeting on September 20, 2011 8:00 a.m. and 5:15 p.m.

Agenda: On September 20, 2011, the committee will meet in open session to hear an overview of the research program in the Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The committee will then discuss and make recommendations on the safety and immunogenicity (surrogate endpoint) of Pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) in adults aged 50 years and older using an accelerated approval regulatory pathway.

Science Board to the Food and Drug Administration

Science Board to the Food and Drug Administration
Meeting on August 19, 2011, from 9 a.m. to 3 p.m.

Agenda: On August 19, 2011, the Science Board will discuss the FDA’s draft Strategic Plan for Regulatory Science. The Board will be provided with an update on the FDA’s Medical Countermeasures Initiative program plans. The Board will also initiate the charges to the subcommittees for: (1) A science review of the Center for Devices and Radiological Health, and (2) a Medical and Biological Engineering review

Arthritis Advisory Committee

Arthritis Advisory Committee
Meeting on September 13, 2011, from 8 a.m. to 5:30 p.m.

Agenda: On September 13, 2011, 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. These drugs are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, postherpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. 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

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee
Meeting on September 9, 2011, from 8 a.m. to 6 p.m. (Day 2 of 2)

Agenda: On September 8 and 9, 2011, 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, including reclassification into Class III (premarket approval), labeling improvements and postmarket surveillance studies. The committee will also consider surgical mesh used to treat stress urinary incontinence.

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee
Meeting on September 8, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)

Agenda: On September 8 and 9, 2011, 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, including reclassification into Class III (premarket approval), labeling improvements and postmarket surveillance studies. The committee will also consider surgical mesh used to treat stress urinary incontinence.

Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee

Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee Meeting on September 9, 2011, from 8 a.m. to 4:30 p.m

Agenda: On September 9, 2011, the committees will discuss the benefits and risks of long-term bisphosphonate use for the treatment and prevention of osteoporosis (thinning and weakening of bones that increases the chance of having a broken bone) in light of the emergence of the safety concerns of osteonecrosis of the jaw (jawbone death) and atypical femur fractures (unusual broken thigh bone) 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, Merck & Co., Inc.; ACTONEL (risedronate sodium) tablets, ATELVIA (risedronate sodium) delayed release tablets, and ACTONEL WITH CALCIUM (Copackaged) (risedronate sodium with calcium carbonate) tablets, Warner Chilcott, LLC; BONIVA (ibandronate sodium) tablets and injection, Roche Therapeutics, Inc.; RECLAST (zoledronic acid) injection, Novartis Pharmaceuticals Corp.; and the generic equivalents for these products, if any.

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Meeting on August 31st 2011, from 8 a.m. to 6 p.m. (Day 2 of 2)

Agenda: On August 30 and 31, 2011, the committee will discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants. This meeting is regarding the discussion of different innovative methodological approaches to the conduct of postmarket studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term safety issues associated with silicone gel breast implants in the real-world setting.

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
August 30th 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)

Agenda: On August 30 and 31, 2011, the committee will discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants. This meeting is regarding the discussion of different innovative methodological approaches to the conduct of postmarket studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term safety issues associated with silicone gel breast implants in the real-world setting.

Blood Products Advisory Committee

Blood Products Advisory Committee
Meeting on August 3, 2011, from 8 a.m. to 2:30 p.m.

Agenda: On August 3, 2011, the committee will discuss measures to preserve the blood supply during a severe emergency. In the afternoon, the committee will hear the following updates: Summary of the June 7–8, 2011, Health and Human Services Advisory Committee on Blood Safety and Availability meeting; summary of the May 17–18, 2011, public workshop on risk mitigation strategies to address procoagulant activity in immune globulin products; and summary of the August 1–2, 2011, Transmissible Spongiform Encephalopathies Advisory Committee meeting.

Blood Products Advisory Committee

Blood Products Advisory Committee
Meeting on August 2, 2011, from 1:30 p.m. to 5 p.m.

Agenda: On August 2, 2011, the committee will discuss a study on the incidence of Trypanosoma cruzi infection in blood donors and its implications for selective testing of blood donors.

Cardiovascular and Renal Drugs Advisory Committee

Cardiovascular and Renal Drugs Advisory Committee
Meeting on September 8, 2011, from 8 a.m. to 5 p.m.

Agenda: On September 8, 2011, the committee will discuss new drug application (NDA) 202439, rivaroxaban tablets, submitted by Johnson & Johnson Pharmaceutical Research and Development, L.L.C., on behalf of Ortho- McNeil-Janssen-Pharmaceuticals, for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart).

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
July 27, 2011, from 8 a.m. to 5 p.m. (Day 2 of 2)

Agenda: On July 27, 2011, the committee will discuss current strategies for FDA’s Office of Pharmaceutical Science implementation of quality by design principles within its review offices, incorporating an update on the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Activities. The committee will also receive awareness presentations on FDA’s current partnering with the United States Pharmacopeia, principally to discuss the Monograph Modernization Program.

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
July 26, 2011, from 8 a.m. to 5:30 p.m. (Day 1 of 2)

Agenda: On July 26, 2011, the committee will discuss presentations by the Office of Generic Drugs (OGD) on bioequivalence issues and quality standards relative to narrow therapeutic index (NTI) drug products as a class. In response to feedback during the April 13, 2010, Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (ACPS–CP) meeting, the committee will further discuss the definition and list of NTI drugs, as well as proposed bioequivalence standards for these products. The committee will also receive awareness presentations relevant to OGD’s ongoing focus on quality and safety of generic drug products. Presentations will outline current activities seeking to better understand the impact of formulation and quality on the performance of generic drug products and current thinking related to potential regulatory pathways for these issues.