FDA's Advisory Meetings（８月30日）
公開日時 2010/09/02 04:00
| Recent And Upcoming FDA Advisory Meetings |
|
| Topic |
Advisory Committee |
Date |
| Class-wide Risk Evaluation and Mitigation Strategy for opioid drugs |
Anesthetic and Life Support Drugs and Drug Safety and Risk Management |
July 22-23 |
| AstraZeneca's Brilinta (ticagrelor) for acute coronary syndrome |
Cardiovascular and Renal Drugs |
28-Jul |
| Pfizer's Revatio (sildenafil) for pediatric pulmonary arterial hypertension |
Cardiovascular and Renal Drugs |
29-Jul |
| Valeant Pharmaceuticals North America's Potiga (ezogabine, formerly retigabine) for adjunctive therapy in patients with partial-onset seizures |
Peripheral and Central Nervous System Drugs |
Aug. 11 |
| Interim report on CDER's pharmacovigilance program; JANUS, the FDA-supported data standard for comparative effectiveness research; FDA's nanotechnology research program |
Science Board |
Aug. 16 |
| Lilly's Cymbalta (duloxetine HCl) for chronic pain |
Anesthetic and Life Support Drugs |
Aug. 19 |
| Jazz Pharmaceuticals' sodium oxybate for fibromyalgia in patients age 18 and up |
Arthritis and Drug Safety and Risk Management |
Aug. 20 |
| Cerexa's ceftaroline fosamil for community-acquired bacterial pneumonia and complicated skin and skin structure infections |
Anti-Infective Drugs |
Sept. 7 |
| Abuse potential of the cough suppressant dextromethorphan and a Drug Enforcement Administration request for a scheduling recommendation for the drug |
Drug Safety and Risk Management |
Sept. 14 |
| Statistically significant higher incidence of major cardiovascular adverse events in the Sibutramine Cardiovascular Outcomes Trial of Abbott's obesity drug Meridia (sibutramine) |
Endocrinologic and Metabolic Drugs |
Sept. 15 |
| Arena's Lorqess (lorcaserin) as an adjunct to diet and exercise for weight management in patients with a body mass index ?30 kg/m2 or ?27 kg/m2 with weight-related co-morbidities |
Endocrinologic and Metabolic Drugs |
Sept. 16 |
| Alkermes' Vivitrol (naltrexone for extended-release injectable suspension) for opioid dependence |
Psychopharmacologic Drugs |
Sept. 16 |
|
Boehringer Ingelheim's Pradaxa (dabigatran
etexilate mesylate) for stroke prevention in atrial fibrillation patients
|
Cardiovascular and Renal Drugs |
Sept. 20 |
| Research updates from the Laboratory of Respiratory and Special Pathogens, the Laboratory of Hepatitis Viruses and the Laboratory of Vector Borne Virus Diseases of CBER's Office of Vaccines Research and Review |
Vaccines and Related Biological Products |
Sept. 21 |
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