ＦDA Advisory Meetings（４月12日）
公開日時 2010/04/14 04:00
| Recent And Upcoming FDA Advisory Meetings |
| Topic |
Advisory Committee |
Date |
| Research updates from the Center for Biologics Evaluation and Research's Laboratory of Cellular Hematology and Laboratory of Biochemistry and Vascular Biology |
Blood Products |
12-Apr |
| Revising bioequivalence approaches for critical dose drugs and the use of partial area under the curve to evaluate ANDAs for products with complex pharmacokinetic profiles |
Pharmaceutical Science and Clinical Pharmacology |
13-Apr |
| Revising bioequivalence approaches through a limitation on point estimates; preventing failure of a marketed product to meet stability specifications through the expiration date; addressing the regulatory challenges of drug-induced phospholipidosis |
Pharmaceutical Science and Clinical Pharmacology |
14-Apr |
| Acura Pharmaceuticals' NDA for Acurox (oxycodone HCl and niacin) tablets for relief of moderate to severe pain, and the results of studies evaluating the addition of niacin to reduce the misuse of oxycodone |
Anesthetic and Life Support Drugs and Drug Safety and Risk Management |
22-Apr |
| The World Health Organization's NDA for artesunate rectal suppositories for initial treatment of acute malaria patients |
Anti-Infective Drugs |
29-Apr |
| Public meeting to nominate voting and non-voting consumer representatives to FDA advisory committees and panels. |
|
30-Apr |
| Questcor Pharmaceuticals' sNDA for H.P. Acthar Gel (repository corticotropin injection) for infantile spasms |
Peripheral and Central Nervous System Drugs |
6-May |
| The unexpected finding of DNA originating from porcine circovirus type 1 in Rotarix, a GlaxoSmithKline vaccine against rotavirus gastroenteritis in infants; advanced analytical detection methods for the characterization of cell substrates, viral seeds and other biological materials used in the production of viral vaccines. |
Vaccines and Related Biological Products |
7-May |
| NicOx's nonsteroidal anti-inflammatory drug naproxcinod for the treatment of the signs and symptoms of osteoarthritis |
Arthritis Drugs and Drug Safety and Risk Management |
12-May |
| Theratechnologies' Egrifta (tesamorelin) for reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy |
Endocrinologic and Metabolic Drugs |
27-May |
| MedImmune's motavizumab to prevent serious lower respiratory tract disease caused by respiratory syncytial virus in high-risk children |
Antiviral Drugs |
2-Jun |
| Novartis Gilenia (fingolimod hydrochloride) to treat relapsing forms of multiple sclerosis |
Peripheral and Central Nervous System Drugs |
10-Jun |
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