FDA's Advisory Meetings（４月11日）
公開日時 2011/04/15 04:00
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| Recent And Upcoming FDA Advisory Meetings |
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| Topic |
Advisory Committee |
Date |
| 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 |
| Safety of ultrasound contrast agents, including Lantheus Medical Imaging's perflutren lipid microsphere injectable suspension, GE Healthcare's perflutren protein-type A microspheres injectable suspension and Bracco Diagnostics' sulfur hexafluoride microbubble injection |
Cardiovascular and Renal Drugs and Drug Safety and Risk Management |
2-May |
| 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 |
| Overviews of research programs in CDER's Laboratory of Biochemistry, Division of Therapeutic Proteins, and Laboratories of Cell Biology, Molecular and Developmental Immunology, and Molecular Oncology in the Division of Monoclonal Antibodies |
Cellular, Tissue and Gene Therapies |
31-May |
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