FDA's Advisory Meetings（11月7日）
公開日時 2011/11/14 04:00
Bitmap
| Recent And Upcoming FDA Advisory Committee Meetings |
|
| Topic |
Advisory Committee |
Date |
| 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 |
| Pfizer's Inlyta (axitinib) to treat patients with advanced renal cell carcinoma and Affymax's peginesatide injection to treat anemia associated with chronic renal failure in adult dialysis patients |
Oncologic Drugs |
Dec. 7 |
| 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 |
| Alexza Pharmaceuticals' Adasuve (loxapine) inhalation powder for acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults; pulmonary safety is a particular concern |
Psychopharmacologic Drugs |
Dec. 12 |
| Pathways for smallpox drug development, including use of animal models of other orthopoxviruses |
Antiviral Drugs |
Dec. 14-15 |
（The Pink Sheet 11月７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