FDA's Advisory Meetings（10月25日）
公開日時 2010/10/27 04:00
| Recent And Upcoming FDA Advisory Meetings |
|
| Topic |
Advisory Committee |
Date |
| Safety concerns with intravenous administration of the anti-seizure drugs phenytoin and fosphenytoin, including Purple Glove Syndrome |
Peripheral and Central Nervous System Drugs and Drug Safety and Risk Management |
Nov. 3 |
| Endoscopically documented gastric ulcers as an outcome measure to evaluate drugs to prevent GI complications of NSAIDs |
Gastrointestinal Drugs |
Nov. 4 |
| Clinical trial results of PPIs for GERD in patients <1: AstraZeneca's Nexium (esomeprazole) and Prilosec (omeprazole), Takeda's Prevacid (lansoprazole) and Pfizer's Protonix (pantoprazole) |
Gastrointestinal Drugs |
Nov. 5 |
| FDA's Strategic Plan for Risk Communication and the Transparency Initiative |
Risk Communication |
Nov. 8-9 |
| Updates on CDER's Pharmacovigilance Program, FDA support of comparative effectiveness research, FDA’s Strategic Science Plan and the FDA Medical Countermeasures Initiative, including planning for its regulatory science component |
Science Board |
Nov. 15 |
| Human Genome Sciences' Benlysta (belimumab) for reducing disease activity in adult patients with active, auto-antibody-positive systemic lupus erythematosus |
Arthritis Drugs |
Nov. 16 |
| Pathway to licensure for protective antigen-based anthrax vaccines for post-exposure prophylaxis using the animal efficacy rule |
Vaccines and Related Biological Products |
Nov. 16 |
| Merck's Gardasil for prevention of anal dysplasia and anal cancer |
Vaccines and Related Biological Products |
Nov. 17 |
| Bristol-Myers Squibb's Yervoy (ipilimumab) for second-line treatment of advanced melanoma; iPR Pharmaceuticals and AstraZeneca's Zictifa (vandetanib) for unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer |
Oncologic Drugs |
Dec. 2 |
| Orexigen Therapeutics' Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for obesity and weight management |
Endocrinologic and Metabolic Drugs |
Dec. 7 |
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