FDA's Advisory Meetings（3月28日）
公開日時 2011/04/01 04:00
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| Recent And Upcoming FDA Advisory Meetings |
|
| Topic |
Advisory Committee |
Date |
| 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 |
| Merck's hepatitis C virus protease inhibitor boceprevir for chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or have failed previous therapy |
Antiviral Drugs |
27-Apr |
| Vertex Pharmaceuticals' hepatitis C virus protease inhibitor telaprevir for chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or have failed previous therapy |
Antiviral Drugs |
28-Apr |
| Channels of information dissemination: tracking dissemination; reaching less accessible target audiences |
Risk Communications |
5-May |
| 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 17-18 |
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