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Info Collection Extension on Device Quality System

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Federal Register notice: FDA submits to OMB an information collection extension for Medical Devices: Current Good Manufacturing Pr...

FDA Warns Dollar Tree on Unsafe OTC Drugs

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FDA warns Dollar Tree about its receipt of over-the-counter drugs manufactured by foreign contract firms that have received FDA Wa...

AstraZeneca/Merck NDA for Neurofibromatosis Drug

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FDA accepts for priority review an AstraZeneca and Merck NDA for MEK 1/2 inhibitor selumetinib for pediatric patients with neurofi...

ICH Q12 Guidance Extends Quality by Design: Analysis

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CGMP consultant Dave Elder analyzes a draft International Conference on Harmonization guidance on technical and regulatory conside...

Pull LASIK Off Market: Waxler

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Former CDRH branch chief Morris Waxler tells CBS News LASIK eye surgery should be pulled from the market due to complications.

Panel Nixes Lilly/Boehringer Diabetes Drug

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes to not recommend approval of Eli Lilly and Boehringer Ingelheims ...

Botanical Safety Consortium Convened

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FDA says the Botanical Safety Consortium has been formally convened under a memorandum of understanding between FDA and two resear...

FDA Approves BeiGenes Brukinsa for Some Lymphomas

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FDA approves BeiGenes Brukinsa capsules to treat some adults with mantle cell lymphoma.

Isorx FDA-483 Released

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FDA releases an FDA-483 with four inspection observations on an inspection at Isorx Corp.

NantHealth Tumor Mutational Burden Assay Cleared

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FDA clears a NantHealth 510(k) for its Omics Core, a whole exome tumor-normal in vitro diagnostic that measures overall tumor muta...