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FDA's Advisory Meetings(10月4日)

公開日時 2010/10/06 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
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

 

 (The Pink Sheet  10月4日号より)  FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから 

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