FDA's Advisory Meetings（3月7日）
公開日時 2011/03/09 04:00
| Recent And Upcoming FDA Advisory Meetings |
|
| Topic |
Advisory Committee |
Date |
| Selection of strains to be included in the influenza virus vaccine for the 2011-2012 season; update on pandemic influenza surveillance |
Vaccines and Related Biological Products |
Feb. 25 |
| Selection of dose, trial design and use of tools such as biomarkers, pharmacogenetics, modeling and simulation in drug trials for orphan and rare diseases |
Pharmaceutical Science and Clinical Pharmacology |
2-Mar |
| Novartis' Arcapta Neohaler (indacaterol maleate) for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema |
Pulmonary-Allergy Drugs |
8-Mar |
| 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 |
| 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 |
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