FDA's Advisory Meetings（12月13日）
公開日時 2010/12/15 04:00
| Recent And Upcoming FDA Advisory Meetings |
|
| Topic |
Advisory Committee |
Date |
| 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 |
| Study design for thromboxane receptor antagonists for prevention of cardiovascular events in heart bypass patients with aspirin intolerance due to immunological adverse reactions |
Cardiovascular and Renal Drugs |
Dec. 8 |
| Research updates from CBER's Tumor Vaccines and Biotechnology Branch |
Cellular, Tissue and Gene Therapies |
Dec. 14 |
| Risk of dengue virus infection in blood donors; murine leukemia virus-related human retroviruses and blood safety |
Blood Products |
Dec. 14 |
| Updates from FDA's Dec. 9-10 workshop on products for patients with severe bleeding due to trauma and other causes and CBER research on hemostasis and plasma derivatives |
Blood Products |
Dec. 15 |
| Alnara Pharmaceuticals' Solpura (liprotamase) for exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy or other conditions |
Gastrointestinal Drugs |
Jan. 12 |
| Avid Radiopharmaceuticals' florbetapir F 18 injection for use in PET imaging of beta-amyloid aggregates in the brain to help exclude diagnosis of Alzheimer's disease |
Peripheral and Central Nervous System Drugs |
Jan. 20 |
| Bayer HealthCare's gadobutrol injection for MRI scans to detect and visualize areas with disrupted blood-brain barrier and/or abnormal vascularity of the central nervous system |
Peripheral and Central Nervous System Drugs |
Jan. 21 |
| Bristol-Myers Squibb's Yervoy (ipilimumab) for second-line treatment of advanced melanoma |
Oncologic Drugs |
Feb. 9 |
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