FDA's Advisory Meetings（7月18日）
公開日時 2011/07/22 04:00
| Recent And Upcoming FDA Advisory Committee Meetings |
|
| Topic |
Advisory Committee |
Date |
| Seattle Genetics' Adcetris (brentuximab vedotin) for relapsed or refractory Hodgkin's lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma |
Oncologic Drugs |
14-Jul |
| Bristol-Myers Squibb/AstraZeneca's dapagliflozin for glycemic control in adults with type 2 diabetes |
Endocrinologic and Metabolic Drugs |
19-Jul |
| Development program of an investigational gastroenterology drug; after a brief open period, the meeting will be closed to allow discussion including proprietary information |
Gastrointestinal Drugs and Drug Safety and Risk Management |
20-Jul |
| |
| CLOSED |
| Centocor Ortho Biotech's Remicade (infliximab) for pediatric patients with moderately to severely active ulcerative colitis |
Gastrointestinal Drugs |
21-Jul |
| Presentations by the Office of Generic Drugs on bioequivalence issues and quality standards for narrow therapeutic index drugs |
Pharmaceutical Science and Clinical Pharmacology |
26-Jul |
| Implementation of Quality by Design principles and other topics |
Pharmaceutical Science and Clinical Pharmacology |
27-Jul |
| Johnson & Johnson's Xarelto (rivaroxaban) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation |
Cardiovascular and Renal Drugs |
Sept. 8 |
| Benefits and risks of long-term use of bisphosphonates such as Merck's Fosamax (alendronate), Warner Chilcott's Actonel/Atelvia (risedronate), Roche's Boniva (ibandronate) and Novartis' Reclast (zoledronic acid) for osteoporosis given safety concerns about osteonecrosis of the jaw and atypical femur fractures |
Reproductive Health Drugs and Drug Safety and Risk Management |
Sept. 9 |
（The Pink Sheet 7月18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