FDA's Advisory Meetings（10月3日）
公開日時 2011/10/11 04:00
| Recent And Upcoming FDA Advisory Committee Meetings |
|
| Topic |
Advisory Committee |
Date |
| 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 |
| Regulatory, academic and industry perspectives on the development of anticoagulant products in children |
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee |
Nov. 2 |
| FDA's guidance on clinical trial design for community-acquired bacterial pneumonia |
Anti-Infective Drugs |
Nov. 3 |
| FDA's guidance on clinical trial design for hospital-acquired bacterial pneumonia and bentilator-associated bacterial pneumonia |
Anti-Infective Drugs |
Nov. 4 |
| 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 Gillian-Barre Syndrome after influenza vaccine among Medicare patients, 2010-11; (portions of this meeting were rescheduled from Sept. 20) |
Vaccines and Related Biological Products |
Nov. 16 |
| Clinical trial design for Salix' Xifaxan (rifaximin) for irritable bowel syndrome with diarrhea |
Gastrointestinal Drugs |
Nov. 16 |
| Design and size of premarketing cardiovascular safety studies for approval of serotonin receptor 4 agonists for chronic idiopathic constipation, constipation-predominant irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease that does not respond to a proton pump inhibitor |
Gastrointestinal Drugs |
Nov. 17 |
| Results of a literature review about communicating quantitative risk and benefit information in prescription drug promotional labeling and print advertising; briefing on FDA's Office of Special Health Issues |
Risk Communication |
Nov. 17 |
| Strategic communication of recent theoretical developments on information use in decision-making |
Risk Communication |
Nov. 18 |
| Risk of venous thromboembolism in drospirenone-containing oral contraceptives, including Bayer HealthCare's Yasmin and Yaz (drospirenone/ethinyl estradiol tablets), Beyaz and Sayfral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) and generics |
Reproductive Health Drugs and Drug Safety and Risk Management |
Dec. 8 |
| Risk of thrombotic and thromboembolic events with Johnson &Johnson's Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) compared to commonly prescribed birth control pills as suggested by post-marketing studies |
Reproductive Health Drugs and Drug Safety and Risk Management |
Dec. 9 |
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