FDA's Advisory Meetings（6月13日）
公開日時 2011/06/15 04:00
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| Recent And Upcoming FDA Advisory Committee Meetings |
|
| Topic |
Advisory Committee |
Date |
| Subcommittee’s report on CDER’s Pharmacovigilance Program; updates on FDA’s nanotechnology research program plans and comparative effectiveness research activities |
Science Board |
20-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 |
| Regeneron Pharmaceuticals' Eylea (aflibercept ophthalmic solution) for treatment of neovascular age-related macular degeneration (wet AMD) |
Dermatologic and Ophthalmic Drugs |
17-Jun |
| Novartis' Ilaris (canakinumab) for treatment of gouty arthritis attacks |
Arthritis |
21-Jun |
| Shire's Firazyr (icatibant) for treatment of acute attacks of hereditary angioedema |
Pulmonary and Allergy Drugs |
23-Jun |
| Development issues for cellular and gene therapy products for retinal disorders, including efficacy endpoints in children and adults, potential safety issues related to repeat or second eye administration, and evaluation of product delivery into target site |
Cellular, Tissue and Gene Therapies |
29-Jun |
| Bristol-Myers Squibb/AstraZeneca's dapagliflozin for glycemic control in adults with type 2 diabetes |
Endocrinologic and Metabolic Drugs |
19-Jul |
| Centocor Ortho Biotech's Remicade (infliximab) for pediatric patients with moderately to severely active ulcerative colitis |
Gastrointestinal Drugs |
21-Jul |
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