FDA's Advisory Meetings（8月29日）
公開日時 2011/08/31 04:00
| Recent And Upcoming FDA Advisory Committee Meetings |
| Topic |
Advisory Committee |
Date |
| Bitmap FDA's draft Strategic Plan for Regulatory Science; FDA's Medical Countermeasures Initiative program plans |
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 |
| ApoPharma/Cato Research's Ferriprox (deferiprone) for treatment of transfusional iron overload with inadequate chelation; 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 Pfizer's Prevnar 13 pneumococcal conjugate vaccine in patients over age 50 under accelerated approval; overview of FDA's Laboratory of Enteric and Sexually Transmitted Diseases research program |
Vaccines and Related Biological Products |
Sept. 20 |
| Pediatric-focused safety reviews under BPCA and PREA for various drugs; informational update on pediatric use of Abbott's HIV treatment Kaletra (lopinavir/ritonavir) |
Pediatric |
Sept. 22-23 |
| 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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