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Medical Device Integrity Act Introduced

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Sens. Cassidy and Baldwin introduce bipartisan legislation to require medical device manufacturers to comply with FDA record reque...

FDA Updates Off-Patent, Off-Exclusivity List

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FDA updates the list of off-patent and off-exclusivity drugs without an approved generic, adding some over-the-counter products.

Guide on Referencing Definition of Device

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Federal Register notice: FDA makes available a draft guidance on Referencing the definition of device in public documents.

Traumatic Brain Injury Eye Assessor in Class 2

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Federal Register notice: FDA classifies the traumatic brain injury eye movement assessment aid into medical device Class 2 (specia...

Biogen to File Alzheimers Confirmatory Trial Protocol

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Biogen says it will submit a final clinical trial protocol to FDA 3/2022 for a required post-marketing trial of its controversial ...

FDA Denies Petition on Eugia Pharma ANDA

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FDA denies a petition questioning Eugia Pharmas use of an ANDA for a generic Makena autoinjector.

Improve Cancer Checkpoint Inhibitor Development: Pazdur

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Oncology Center of Excellence director Richard Pazdur and chief of medical oncology Julia Beaver call for changes in the developme...

FTC Should Look Into Par Vasostrict Petition: FDA

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FDA denies a Par Sterile Products petition saying it failed to raise valid scientific or regulatory issues and was submitted as a ...

Guide on Inspecting Injectables for Particulates

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FDA posts a draft guidance entitled Inspection of Injectable Products for Visible Particulates.

Proposed Rule on QSR Harmonization Soon: Maisel

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CDRH Office of Product Evaluation and Quality director William H. Maisel tells an industry conference that the agency is planning ...