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FDA's Advisory Meetings（7月23日）

公開日時　2012/07/24 04:00
Topic
 Advisory Committee Date
Evaluation of radiographic review in randomized clinical trials using progression-free survival as a primary endpoint in non-hematologic malignancies Oncologic Drugs 24-Jul
Whether pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information Oncologic Drugs 25-Jul
Genentech's Lucentis (ranibizumab) for diabetic macular edema Dermatologic and Ophthalmic Drugs July 26 (a.m.)
ThromboGenics' Jetrea (ocriplasmin intravitreal injection) for symptomatic vitreomacular adhesions including macular hole Dermatologic and Ophthalmic Drugs July 26 (p.m.)
Uses and limitations of in vitro dissolution testing and proposals for evaluation and future research; update on FDA’s recent draft guidances on biosimilars Pharmaceutical Science and Clinical Pharmacology Aug. 8
FDA’s draft guidance on tablet scoring Pharmaceutical Science and Clinical Pharmacology Aug. 9 (a.m.)
CDER's Nanotechnology Risk Management Working Group and nanotechnology-related research, and an overview and preliminary analysis of nanotechnology-related information collected from drug application submissions Pharmaceutical Science and Clinical Pharmacology Aug. 9 (p.m.)
Abbott’s Humira (adalimumab) for reducing signs and symptoms and achieving clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy Gastrointestinal Drugs Aug. 28
Novartis' tobramycin inhalation powder for management of cystic fibrosis patients infected with Pseudomonas aeruginosa Anti-Infective Drugs Sept. 5
Novartis' imatinib mesylate as adjunctive therapy for pulmonary arterial hypertension (WHO Diagnostic Group 1) to improve exercise capacity and cardiopulmonary hemodynamics in patients who remain symptomatic despite treatment with two or more approved vasodilator therapies Cardiovascular and Renal Drugs Sept. 14
The appropriateness of using cell lines derived from human tumors for making vaccines Vaccines and Related Biological Products Sept. 19

 

 

 

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