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FDA Posts UDI Final Rule for Medical Devices

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FDA issues a long-awaited final rule on establishing a unique device identifier system to identify devices through distribution an...

Petition Seeks Confusion Warning on Anticholinergic Products

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A citizen petition seeks a warning to the labeling of all nonprescription drug products containing an ingredient with anticholiner...

Petition Lingered 21 Years at FDA Until Just Denied

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FDA denies a 21-year-old citizen petition seeking the market withdrawl of doxylamine succinate.

Guidance on Endocrine Disruption Potential of Drugs

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Federal Register Notice: FDA releases a draft guidance: Endocrine Disruption Potential of Drugs: Nonclinical Evaluation.

FTC Plans Workshop on Native Advertising

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The Federal Trade Commission plans a 12/4 workshop to examine the practice of blending advertisements with news, entertainment, an...

FDA Panel Backs ReSure Cataract Surgery Sealant

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FDAs Ophthalmic Devices Panel votes that an Ocular Therapeutix PMA for ReSure Sealant is safe and effective for managing clear cor...

Phase 3 Study with GSKs Oligonucleotide Misses Endpoint

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A GlaxoSmithKline and Prosensa Phase 3 clinical study involving drisapersen, misses the primary endpoint.

Baxter Recalls 2 Lots of Dual Luer Lock Caps

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Baxter International recalls two lots of its Dual Luer Lock Caps because of the presence of loose particulate matter found in the ...

CDER Science Chief Webber Retires to Join Perrigo

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CDER Office of Pharmaceutical Science acting director Keith Webber retires to accept a position with Perrigo effective 10/18.

FDA Approves Teva sNDA for Liquid Treanda

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FDA approves a Teva Pharmaceutical Industries supplemental NDA for Treanda (bendamustine HCI) injection in a new liquid formulatio...