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Only 58% of Drug Postmarketing Requirements Filed on Time

[ Price : $8.95]

The latest FDA report on the status of postmarketing requirements and commitments shows that drug and biologic companies submit an...

Attorneys Weigh FDA Reporting of Cybersecurity Upgrades

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A client alert by DLA Piper attorneys reviews when a cybersecurity-related change to a device is reportable to FDA.

FDA Allows Marketing of Becton Dickinson Vaginitis Assay

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FDA approves a de novo petition to allow marketing of a Becton Dickinson molecular test to detect the most common causes of vagini...

FDA Clears Onkos Limb Salvage System

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FDA clears an Onkos Surgical 510(k) for the Eleos Limb Salvage System to treat patients with significant bone loss due to cancer, ...

FDA, Catalyst Agree on Trial Protocol for LEMS Therapy

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FDA and Catalyst Pharmaceuticals reach an agreement under a special protocol assessment for the protocol design, clinical endpoint...

Lawmakers Face Tug-of-war Over 21st Century Cures Bills

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Medical research groups call on the House and Senate leadership to pass the 21st Century Cures Act when they return to work in Nov...

Washington Legal Foundation Examines Off-label Promotion

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A Washington Legal Foundation legal backgrounder examines the recent convictions of two Acclarent (Johnson & Johnson subsidiary) e...

Comments Sought on BLA Reporting Requirements Extension

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Federal Register Notice: FDA seeks comments on a submission to OMB seeking to extend an information collection related to BLA gene...

Comments Sought on Device Educational Program Surveys Extension

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Federal Register Notice: FDA seeks comments on a submission to OMB seeking to extend an information collection related to Testing ...

FDA OKs St. Jude Stroke Reducing Device

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FDA approves a St. Jude Medical PMA for the Amplatzer PFO Occluder device to reduce the risk of a stroke in patients who previousl...