FDA Advisory Meetings（11月９日）
公開日時 2009/11/11 04:00
| Recent And Upcoming FDA Advisory Meetings |
| Topic |
Advisory Committee |
Date |
| Discussion of strategies and programs designed to communicate with the public about the risks and benefits of FDA-regulated products |
Risk Communication |
Nov. 12-13 |
| Committee will hear updates on several topics including the 2009 A/H1N1 pandemic and the impact on blood safety and availability |
Blood Products |
Nov. 16-17 |
| Genentech/Novartis' Xolair (omalizumab) for moderate to severe persistent allergic asthma in patients between six and 11 years of age |
Pulmonary-Allergy Drugs |
Nov. 18 |
| On Nov. 18, a discussion of Pfizer's (formerly Wyeth's) pneumococcal 13-valent conjugate vaccine Prevnar 13 and an update on FDA's H1N1 influenza vaccine activities; on Nov. 19, a discussion of an influenza vaccine, purified recombinant influenza hemagglutinin |
Vaccines and Related Biological Products |
Nov. 18-19 |
| Boehringer Ingelheim's Spiriva HandiHaler (tiotropium inhalation powder) for the reduction in exacerbations in patients with chronic obstructive pulmonary disease |
Pulmonary-Allergy Drugs |
Nov. 19 |
| Pharmaxis' Aridol (mannitol bronchial challenge test) to assess bronchial hyperresponsiveness to help diagnose asthma |
Pulmonary-Allergy Drugs |
Nov. 20 |
| Novartis' everolimus to prevent rejection of transplanted kidneys |
Cardiovascular and Renal Drugs |
Dec. 7 |
| Discussion of 16 pediatric-focused safety reviews and brief update on atypical antipsychotic drugs as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act |
Pediatric Advisory Committee |
Dec. 8 |
| Discussion of safety considerations for gadolinium-based contrast agents used with magnetic resonance imaging scans |
Cardiovascular and Renal Drugs and Drug Safety and Risk Management |
Dec. 8 |
| Discussion of endpoints and other clinical trial design issues in the development of antibacterial products for community-acquired bacterial pneumonia |
Anti-Infective Drugs |
Dec. 9 |
| Gilead Science's inhaled aztreonam to treat respiratory symptoms and pulmonary function in cystic fibrosis patients with bacterial infection Pseudomonas aeruginosa |
Anti-Infective Drugs |
Dec. 10 |
| Discussion of FDA expectations for development of pediatric formulation of cancer drugs and dosing regimens in infants and toddlers with cancer |
Pediatric Oncology Subcommittee |
Dec. 15 |
| AstraZeneca's sNDA for Crestor (rosubastatin) to prevent cardiovascular disease based on the results of the JUPITER trial |
Endocrinologic and Metabolic Drugs |
Dec. 15 |
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