FDA's Advisory Meetings（9月19日）
公開日時 2011/09/27 04:00
| Recent And Upcoming FDA Advisory Committee Meetings |
| Topic |
Advisory Committee |
Date |
| ApoPharma/Cato Research's Ferriprox (deferiprone) for treatment of transfusional iron overload with inadequate chelation |
Oncologic Drugs |
Sept. 14 |
| Clinical trial designs and endpoints for products to treat patients with non-metastatic castration-resistant prostate cancer who have a rising serum level of prostate-specific antigen despite being on androgen deprivation therapy |
Oncologic Drugs |
Sept. 14 |
| Overview of FDA's Laboratory of Enteric and Sexually Transmitted Diseases research program |
Vaccines and Related Biological Products |
Sept. 20 |
| Pediatric-focused safety reviews under BPCA and PREA for various drugs; informational update on pediatric use of Abbott's HIV treatment Kaletra (lopinavir/ritonavir) |
Pediatric |
Sept. 22-23 |
| Teva Neuroscience's Azilect (rasagiline) for idiopathic Parkinson's disease to slow clinical progression and treat signs and symptoms, as initial monotherapy and as adjunct therapy to levodopa |
Peripheral and Central Nervous System Drugs |
Oct. 17 |
| Merck's Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe), in combination with simvastatin, to reduce major cardiovascular events in patients with chronic kidney disease |
Endocrinologic and Metabolic Drugs |
Nov. 2 |
| Surrogate endpoint (safety and immunogenicity) for Pfizer's Prevnar 13 pneumococcal conjugate vaccine in patients over age 50 under accelerated approval; overview of research in the Laboratory of Method Development; update on evaluation of Gullian-Barre Syndrome after influenza vaccine among Medicare patients, 2010-11; (portions of this meeting wer e rescheduled from Sept. 20). |
Vaccines and Related Biological Products |
Nov. 16 |
（The Pink Sheet 9月19日号より） FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから