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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Premium Production and Results RNA.

FDA Confident Zolgensma Should Stay on Market

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FDA says it is confidence that AveXis Zolgensma should remain on the market despite manufacturer reports of a data manipulation pr...

Comments on Clinical Trial Diversity Guidance

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Three stakeholders suggest changes to an FDA draft guidance on clinical trial diversity enhancement.

Biosimilar User Fee Rate for FY 2020 Set

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Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2020.

PhRMA Suit on California Pricing Law Can Proceed: Court

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A California federal court allows an amended complaint by Pharmaceutical Research and Manufacturers of America against a Californi...

AbbVie NDA for Uterine Fibroid Bleeding

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AbbVie files an NDA for elagolix, an oral gonadotropin-releasing hormone antagonist with a proposed indication for managing heavy ...

Legislation Needed to Move Away from Predicate-based 510(k)s

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A JAMA viewpoint says legislation is needed to codify changes FDA is seeking to its medical device 510(k) program to reduce the re...

Foamix Pharmaceuticals NDA for Rosacea Foam

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Foamix Pharmaceuticals files an NDA seeking approval for FMX103 foam for treating moderate-to-severe papulopustular rosacea in pat...

Draft Guide on Device MRI Safety

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Federal Register notice: FDA makes available a draft guidance on medical device MRI-safety testing and labeling.

Bracco Diagnostics Aribar Thin Liquid OKd

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FDA approves Bracco Diagnostics Aribar Thin Liquid (barium sulfate) for oral suspension, indicated for modified barium swallow stu...