FDA Advisory Meetings（３月１日）
公開日時 2010/03/03 04:05
| Topic |
Advisory Committee |
Date |
| Forest Laboratories' sNDA for nebivolol for chronic heart failure |
Cardiovascular and Renal Drugs |
Jan. 11 |
| 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 |
| Cell Therapeutics' Pixuvri (pixantrone dimaleate injection) for single agent treatment of recurring or refractory aggressive non-Hodgkins lymphoma in patients who have received two or more prior lines of therapy; ChemGenex's Omapro (omacetaxine mepesuccinate injection) for treatment of adults with chronic myeloid leukemia who have the Bcr-Abl T315I mutation and have failed on imatinib therapy |
Oncologic Drugs |
Feb. 10 |
| POSTPONED |
| Plans to establish another subcommittee to review research programs at CDER; updates of science programs at the Office of Regulatory Affairs and the National Center for Toxicological Research |
Science Board |
Feb. 22 |
| Selection of strains to be included in the influenza virus vaccine for the 2010-2011 influenza season |
Vaccines and Related Biological Products |
Feb. 22 |
| Salix's Xifaxan (rifaximin) for maintenance of remission of hepatic encephalopathy |
Gastrointestinal Drugs |
Feb. 23 |
| Strategies and lessons from a selection of FDA's previously issued communications, emphasizing communications challenges |
Risk Communication |
Feb. 25-26 |
| Bristol-Myers Squibb's belatacept for use with kidney transplants to prevent rejection of the transplanted kidney |
Cardiovascular and Renal Drugs |
1-Mar |
| InterMune's pirfenidone for treatment of idiopathic pulmonary fibrosis |
Pulmonary-Allergy Drugs |
9-Mar |
| Clinical trial design to evaluate serious asthma outcomes with the class of long-acting beta-2 adrenergic agonist drugs in adults, adolescents and children |
Pulmonary-Allergy Drugs and Drug Safety and Risk Management |
March 10-11 |
| Pharmacogenomics in early drug development; a new patient-centric clinical pharmacology approach to drug safety; the design and analysis of clinical pharmacology studies, focusing on patients with kidney impairment; and transporter-mediated drug interactions. |
Pharmaceutical Science and Clinical Pharmacology |
17-Mar |
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