FDA Advisory Meetings（10月26日）
公開日時 2009/11/02 04:00
| Topic |
Advisory Committee |
Date |
| ApoPharma's Ferriprox (deferiprone) as an iron chelating agent to treat iron overload or build-up in patients with transfusion-dependent thalassemia or other transfusion-dependent anemias |
Oncologic Drugs |
Oct. 6 |
| Pfizer's Selzentry (maraviroc) for supplemental indication to treat antiretroviral-naïve patients with chemokine (c-c motif) receptor 5 (CCR5) tropic human immunodeficiency virus |
Antiviral Drugs |
Oct. 8 |
| Fibrocell Technologies' Isolagen Therapy, BLA 125348, for moderate to severe nasolabial fold wrinkles |
Cellular, Tissue and Gene Therapies |
Oct. 9 |
| Acorda Therapeutics' Amaya (fampridine-SR) to improve walking ability in multiple sclerosis patients |
Peripheral and Central Nervous System Drugs |
Oct. 14 |
| Discussion of updated susceptibility test information in systemic antibacterial drug product labeling |
Anti-Infective Drugs |
Oct. 26 |
| Human Genome Sciences' raxibacumab injection to treat inhalational anthrax disease |
Anti-Infective Drugs |
Oct. 27 |
| 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 |
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