FDA's Advisory Meetings（3月14日）
公開日時 2011/03/18 04:00
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| Recent And Upcoming FDA Advisory Meetings |
| Topic |
Advisory Committee |
Date |
| Implications for clinical practice and preclinical and clinical studies of findings on degeneration in the nervous system in juvenile animals exposed to anesthetic drugs, and from human epidemiological studies on the use of anesthesia in children |
Anesthetic and Life Support Drugs |
10-Mar |
| Use of historical-controlled trials in antiepileptic drugs already approved as adjunctive therapy for use as anticonvulsant monotherapy for seizures of partial origin, including consideration of GlaxoSmithKline's Lamictal XR (lamotrigine) for monotherapy in patients age 13 years and older |
Peripheral and Central Nervous System Drugs |
10-Mar |
| Optimer Pharmaceuticals' fidaxomicin tablets for Clostridium difficile infection in adults |
Anti-Infective Drugs |
5-Apr |
| Updates of research by CBER's Laboratory of Bacterial Polysaccharides; immunological markers for demonstrating effectiveness of meningococcal serogroups A, C, Y, and W-135; conjugate vaccines for children under age 2; approaches to licensure of meningococcal serogroup B vaccines |
Vaccines and Related Biological Products |
April 6-7 |
| Novartis' Afinitor (everolimus) for advanced neuroendocrine tumors of gastrointestinal, lung or pancreatic origin and CP Pharmaceuticals/Pfizer's Sutent (sunitinib malate) for unresectable pancreatic neuroendocrine tumors |
Oncologic Drugs |
12-Apr |
| Whether new dosing information should be added to the labels of oral OTC acetaminophen drugs for children under 2, whether a weight-based dosing regimen should be added for children age 2 to 12, and how to reduce medication errors. |
Nonprescription Drugs and Pediatric |
May 17- |
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