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FDA Clears Onkos Limb Salvage System

[ Price : $8.95]

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...

FDA Status Report on NDA/BLA Postmarketing Requirements

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Federal Register Notice: FDA makes available an annual report on the status of postmarketing requirements and postmarketing commit...

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...

FDA Guidance on Essure-type Device Labeling and Warnings

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FDA releases a guidance on Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization that addresse...

FDA Clears Corindus New CorPath Vascular Robotic System

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FDA clears a Corindus Vascular Robotics 510(k) for the CorPath GRX, the second generation of its CorPath Vascular Robotic System.