FDA Advisory Meetings（12月７日）
公開日時 2009/12/09 04:00
| Recent And Upcoming FDA Advisory Meetings |
| Topic |
Advisory Committee |
Date |
| 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 (rosuvastatin) to prevent cardiovascular disease based on the results of the JUPITER trial |
Endocrinologic and Metabolic Drugs |
Dec. 15 |
| Updates on research programs in several CBER laboratories, the Division of Viral Products, and the Office of Vaccines Research and Review |
Vaccines & Related Biological Products |
Dec. 15 |
| OSI Pharmaceuticals' Tarceva (erlotinib) for non-small cell lung cancer, and GlaxoSmithKline's Tykerb (lapatinib) for use in combination with an aromatase inhibitor to treat hormone sensitive advanced or metastatic breast cancer |
Oncologic Drugs |
Dec. 16 |
| Photocure ASA's Hexvix (hexaminolevulinate as hydrochloride) kit for the preparation of the diagnostic imaging agent Hexvix for intravesical use |
Oncologic Drugs |
Dec. 17 |
| On Jan. 12, Actelion Pharmaceuticals' Zavesca (miglustat) to treat progressive neurological manifestations in patients with Niemann-Pick Disease; On Jan. 13, Orphan Europe SARL's Carbaglu (carglumic acid) for hyperammonemia in patients with N acetyl glutamate synthetase deficiency |
Endocrinolgic and Metabolic Drugs |
Jan. 12-13 |
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