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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites BioMerieux, CanineCare.us,, Elite Massagers, Health Research Laboratories, LLC/N...

Comments Sought on Animal Extralabel Drug Use

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Federal Register Notice: FDA seeks comments on reporting requirements for extralabel drug use in animals.

Woodcock Discusses Collaborations to Advance Drug Development Science

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CDER director Janet Woodcock discusses collaborative efforts to advance regulatory science.

FDA Study Finds Reduce Risks for Pradaxa Compared to Warfarin

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An FDA study finds that Boehringer Ingelheim Pharmaceuticalss Pradaxa (dabigatran etexilate mesylate) was associated with reduced ...

Astellas Granted Orphan Status for Antifungal

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FDA grants Astellas an orphan drug designation for isavuconazole and its use in treating invasive candidiasis.

FDA Accepts Boehringer NDA for Spiriva Respimat for Asthma

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FDA accepts for review a Boehringer Ingelheim NDA for Spiriva Respimat (tiotropium bromide) inhalation spray that is seeking an in...

FDA Partially Approves Petition on Proton Pump Safety

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FDA partially approves a 2011 Public Citizen petition calling on FDA to require labeling changes to all proton pump inhibitors.

Biosimilars Could Save U.S. $44 Billion: Analysis

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A new RAND Corp. analysis says that biosimilar products have the potential to cut spending on biologics in the U.S. by $44 billion...

Richard-Allan Scientific Class 1 Recall of Tissue Preservative

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Richard-Allan Scientific begins a Class 1 recall of its 10% Neutral Buffered Formalin due to product concentration concerns.

Revive Plans Trial for Bucillamine in Gout Patients

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Revive Therapeutics files an IND to FDA for REV-002 (bucillamine) for treating gout.