FDA's Advisory Meetings（11月15日）
公開日時 2010/11/18 04:00
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| Recent And Upcoming FDA Advisory Meetings |
|
| Topic |
Advisory Committee |
Date |
| Human Genome Sciences' Benlysta (belimumab) for lupus |
Arthritis Drugs |
Nov. 16 |
| Pathway to licensure for protective antigen-based anthrax vaccines for post-exposure prophylaxis using the animal efficacy rule |
Vaccines and Related Biological Products |
Nov. 16 |
| Merck's Gardasil for prevention of anal dysplasia and anal cancer |
Vaccines and Related Biological Products |
Nov. 17 |
| Testing of replication competent retrovirus/lentivirus in retroviral and lentiviral vector-based gene therapy products |
Cellular, Tissue and Gene Therapies |
Nov. 19 |
| Pediatric development plans for Pfizer's crizotinib, Allos' pralatrexate, Amgen's denosumab and Eisai's eribulin, which were recently approved or in late-stage trials for an adult oncology use |
Oncologic Drugs/Pediatric Oncology Subcommittee |
Nov. 30 |
| GlaxoSmithKline's Avodart and Merck's Proscar for prostate cancer risk reduction |
Oncologic Drugs |
Dec. 1 |
| Bristol-Myers Squibb's Yervoy (ipilimumab) for second-line treatment of advanced melanoma; iPR Pharmaceuticals/ AstraZeneca's Zictifa (vandetanib) for unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer |
Oncologic Drugs |
Dec. 2 |
| Endo Pharmaceuticals' extended-release oxymorphone for extended, around-the clock relief of moderate to severe pain |
Anesthetic and Life Support Drugs/Drug Safety and Risk Management |
Dec. 2 |
| Pediatric safety reviews of various drugs under PREA and BPCA |
Pediatric |
Dec. 7 |
| Orexigen Therapeutics' Contrave for obesity and weight management |
Endocrinologic and Metabolic Drugs |
Dec. 7 |
| Research updates from CBER's Tumor Vaccines and Biotechnology Branch |
Cellular, Tissue and Gene Therapies |
Dec. 14 |
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