FDA's Advisory Meetings（5月2日）
公開日時 2011/05/09 04:00
Bitmap
| Recent And Upcoming FDA Advisory Meetings |
|
| Topic |
Advisory Committee |
Date |
| 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 |
| FDA's risk communications programs, including different channels for information dissemination, tracking how information is gathered and spread, and reaching less accessible target audiences |
Risk Communications |
5-May |
| Ethics of subtherapeutic doses of investigational drugs in children, e.g. to determine drug metabolism, disposition and targeting |
Pediatric Ethics Subcommittee of the Pediatric Advisory Committee |
11-May |
| Pediatric safety reviews under BPCA and PREA for various drugs; findings of the Pediatric Ethics Subcommittee from May 11 |
Pediatric |
16-May |
| Changes to dosing information for oral OTC acetaminophen drugs for children under 2, a weight-based dosing regimen for children 2 to 12, and reducing medication errors |
Nonprescription Drugs and Pediatric |
May 17-18 |
| The ACCORD Lipid trial of Abbott's Trilipix (fenofibric acid) |
Endocrinologic and Metabolic Drugs |
19-May |
| 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 |
| Cellular and gene therapy products for retinal disorders |
Cellular, Tissue and Gene Therapies |
29-Jun |
（The Pink Sheet 5月2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