FDA Advisory Meetings（７月５日）
公開日時 2010/07/08 04:00
| Topic |
Advisory Committee |
Date |
| Cardiovascular safety of GlaxoSmithKline's diabetes drug Avandia (rosiglitazone maleate) |
Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management |
July 13-14 |
| Vivus' Qnexa (phentermine/topiramate) as an adjunct to diet and exercise for weight management in patients with a body mass index of 30 kg per square meter, or 27 kg per square meter or more if accompanied by weight-related co-morbidities |
Endocrinologic and Metabolic Drugs |
15-Jul |
| Genentech's Avastin (bevacizumab) for first-line treatment of metastatic, HER2-negative breast cancer in women, in combination with docetaxel, capecitabine, or taxanes and anthracyclines; the committee also will consider converting the existing accelerated approval to full approval for treatment in combination with paclitaxel for patients who have not received chemotherapy for locally recurrent or metastatic HER2-negative breast cancer |
Oncologic Drugs |
20-Jul |
| Class-wide Risk Evaluation and Mitigation Strategy for opioid drugs |
Anesthetic and Life Support Drugs and Drug Safety and Risk Management |
July 22-23 |
| Blood safety and availability, emerging arboviruses, emerging infectious diseases, the Q fever epidemic in the Netherlands, xenotropic murine leukemia virus-related virus, the risk of babesia infection by blood transfusions and the status of laboratory tests |
Blood Products |
26-Jul |
| Blood donor hemoglobin/hematocrit qualifications standards, iron status and interdonation interval |
Blood Products |
27-Jul |
| AstraZeneca's 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) 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 |
| Jazz Pharmaceuticals' sodium oxybate for fibromyalgia in patients age 18 and up |
Arthritis and Drug Safety and Risk Management |
Aug. 20 |
| 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 |
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