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Serious BIMO Inspections Soar 10-fold

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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...

FDA Appeals Drug Compounding Case

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FDA appeals a Florida federal judges 9/12 ruling that the Federal Food, Drug, and Cosmetic Act does not give the agency the author...

FDA Lifts Hold on Interferon Cervical Lesion Trial

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FDA removes a clinical hold on Helix BioPharmas Phase 2-3 trial involving its topical interferon alpha-2b product in low-grade cer...

FDA Approves IntelGenx Depressive Disorder Drug

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FDA has approved an IntelGenx NDA for CPI-300, indicated for patients with major depressive disorder.

FDA Complete Response on Iluvien NDA

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FDA issues a complete response letter for an Alimera Sciences NDA for Iluvien for treating diabetic macular edema.

Guidance on IDE Clinical Investigations

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Federal Register Notice: FDA releases a draft guidance, FDA Decisions for Investigational Device Exemption (IDE) Clinical Investig...

FDA Clears Cardiosave Intra-aortic Balloon Pump

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FDA clears a Maquet Cardiovascular 510(k) for the Cardiosave intra-aortic balloon pump.

Penn State Analogy Draws Fire at FDA

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FDA employees attack a commentary by FDA Webview editor Jim Dickinson that drew a comparison between the culture of blind loyalty ...

Pilot Program Participants Sought for IDEs

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Federal Register Notice: FDA solicits nominations from device sponsors to participate in a pilot program for early feasibility stu...

Bill Aims to Boost Grandfathered Dietary Ingredients

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Rep. Dan Burton introduces a bill to move the date used to determine a dietary ingredient that is eligible to be grandfathered.