FDA's Advisory Meetings（8月1日）
公開日時 2011/08/04 04:00
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| Recent And Upcoming FDA Advisory Committee Meetings |
|
| Topic |
Advisory Committee |
Date |
| FDA's draft Strategic Plan for Regulatory Science; FDA's Medical Countermeasures Initiative program plans; charges to Science Board subcommittees |
Science Board |
Aug. 19 |
| Johnson & Johnson's Xarelto (rivaroxaban) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation |
Cardiovascular and Renal Drugs |
Sept. 8 |
| Benefits and risks of long-term use of bisphosphonates such as Merck's Fosamax (alendronate), Warner Chilcott's Actonel/Atelvia (risedronate), Roche's Boniva (ibandronate) and Novartis' Reclast (zoledronic acid) for osteoporosis, given safety concerns about osteonecrosis of the jaw and atypical femur fractures |
Reproductive Health Drugs and Drug Safety and Risk Management |
Sept. 9 |
| Safety and other issues with the anti-nerve growth factor class |
Arthritis |
Sept. 13 |
| ApoPharma/Cato Research's Ferriprox (deferiprone) for treatment of transfusional iron overload when current chelation therapy is inadequate; trial designs and endpoints for products to treat patients with non-metastatic castration-resistant prostate cancer who have a rising serum level of prostate-specific antigen despite being on androgen deprivation therapy |
Oncologic Drugs |
Sept. 14 |
| Surrogate endpoint (safety and immunogenicity) for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) in patients age 50 and up under accelerated approval; overview of the research program of FDA's Laboratory of Enteric and Sexually Transmitted Diseases |
Vaccines and Related Biological Products |
Sept. 20 |
| Teva Neuroscience's Azilect (rasagiline) for idiopathic Parkinson's disease to slow clinical progression and treat signs and symptoms as initial monotherapy and as adjunct therapy to levodopa |
Peripheral and Central Nervous System Drugs |
Oct. 17 |
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