FDA's Advisory Meetings（10月11日）
公開日時 2010/10/14 04:00
| Recent And Upcoming FDA Advisory Meetings |
|
| Topic |
Advisory Committee |
Date |
| Analyses of the TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) study of Amgen's Aranesp (darbepoetin alfa) |
Cardiovascular and Renal Drugs |
Oct. 18 |
| Design of post-marketing abuse potential studies for Purdue's OxyContin (oxycodone) and Alpharma and King's Embeda (morphine sulfate extended-release with a sequestered naltrexone inner core) |
Anesthetic and Life Support Drugs and Drug Safety and Risk Management |
Oct. 21-22 |
| 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 |
| The adequacy of endoscopically documented gastric ulcers as an outcome measure to evaluate drugs intended to prevent gastrointestinal complications of nonsteroidal anti-inflammatory drugs, including aspirin |
Gastrointestinal Drugs |
Nov. 4 |
| Results of clinical trials of proton pump inhibitors for gastroespohageal reflux disease in patients less than 1 year old: 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 |
| Human Genome Sciences' Benlysta (belimumab) for reducing disease activity in adult patients with active, auto-antibody-positive systemic lupus erythematosus |
Arthritis Drugs |
Nov. 16 |
| The pathway to licensure for protective antigen-based anthrax vaccines for a post-exposure prophylaxis indication using the animal rule (testing in animals in lieu of clinical trials) |
Vaccines and Related Biological Products |
Nov. 16 |
| Merck's Gardasil for the prevention of anal dysplasia and anal cancer |
Vaccines and Related Biological Products |
Nov. 17 |
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