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New FDA statistics show that serious (OAI) CDER clinical trial-related inspections soared 10-fold in the past eight years and that...[ Price : $8.95]
FDA appeals a Florida federal judges 9/12 ruling that the Federal Food, Drug, and Cosmetic Act does not give the agency the author...[ Price : $8.95]
FDA removes a clinical hold on Helix BioPharmas Phase 2-3 trial involving its topical interferon alpha-2b product in low-grade cer...[ Price : $8.95]
FDA has approved an IntelGenx NDA for CPI-300, indicated for patients with major depressive disorder.[ Price : $8.95]
FDA issues a complete response letter for an Alimera Sciences NDA for Iluvien for treating diabetic macular edema.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance, FDA Decisions for Investigational Device Exemption (IDE) Clinical Investig...[ Price : $8.95]
FDA clears a Maquet Cardiovascular 510(k) for the Cardiosave intra-aortic balloon pump.[ Price : $8.95]
FDA employees attack a commentary by FDA Webview editor Jim Dickinson that drew a comparison between the culture of blind loyalty ...