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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 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 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...

Watson ANDA for Generic Exelon

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Watson Labs files an ANDA for a generic equivalent of Novartis Exelon patch used for treating mild to moderate dementia associated...

FDA OKs Watson Kadian Generic

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FDA approves a Watson Pharmaceuticals ANDA for morphine sulfate extended-release capsules, a generic of Actavis Kadian.

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...

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.

Feds Want Merck Drug Marketing Info

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Merck says it is cooperating with federal probes into marketing of Integrilin, Avelox, and AzaSite.

FDA Approves Hemacord Cell Therapy

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FDA approves Hemacord, the first hematopoietic progenitor cells-cord cell therapy.

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 ...