FDA's Advisory Meetings（10月17日）
公開日時 2011/10/20 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 |
| Pediatric development plans for GSK's Votrient (pazopanib) and three investigational cancer drugs: Adherex Technologies' sodium thiosulfate injection, Genentech's vismodegib and MedImmune's Medi-573 (fully human antibody to IGF-I and IGF-II) |
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee |
Nov. 1 |
| 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 |
| Draft guidance on clinical trial design for community-acquired bacterial pneumonia |
Anti-Infective Drugs |
Nov. 3 |
| Draft guidance on clinical trial design for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia |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 |
| Issues related to Risk Evaluation and Mitigation Strategies, looking at the iPLEDGE program for isotretinoin as an example of a REMS with elements to assure safe use and considering general issues about the impact of REMS with ETASU on the health care system and patient access, including how ETASU could be better integrated into existing health systems |
Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs |
Dec. 1 |
| 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 |
| Pathways for smallpox drug development, including use of animal models of other orthopoxviruses |
Antiviral Drugs |
Dec. 14-15 |
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