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Concerns Over FDA Biosimilar Labeling Draft Guide

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Four stakeholders differ on an FDA draft guidance suggesting a new approach to biosimilar labeling on interchangeability.

Repeat CGMP Violations at Cipla Plant

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FDA warns Cipla about CGMP and other violations at its Madhya Pradesh, India-based drug manufacturing facility.

SoClean Recalls CPAP Device Cleaners

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SoClean recalls its SoClean2 and SoClean3 equipment that is used to clean, sanitize, or disinfect CPAP sleep apnea devices and acc...

Study New Guide on Science Info for MDs: Attorneys

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Three Epstein Becker Green attorneys analyze a new FDA draft guidance on communicating scientific information on unapproved uses o...

Medtronics Symplicity for Hypertension Approved

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FDA approves a Medtronic PMA for its Symplicity Spyral renal denervation system for treating hypertension.

Abecma Review Delayed for Panel Input

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FDA delays a 12/16-expected review decision on a Bristol Myers Squibb and 2seventy bio supplemental BLA for Abecma (idecabtagene v...

Meeting on Rare Disease Patient Engagement

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Federal Register notice: FDA announces a 12/14 public meeting entitled Advancing the Development of Therapeutics Through Rare Dise...

Info Sought on Supply Chain Security

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Federal Register notice: FDA seeks information to better understand the status of trading partners interoperable systems and proce...

Final Rule on DTC Ads Major Statements

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A new final rule outlines five standards that the agency says drug marketers must follow to ensure their direct-to-consumer advert...

Bayer Stops Stroke Drug Study Over Inferiority

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Bayer stops its Phase 3 OCEANIC-AF study evaluating asundexian compared to apixaban (Bristol-Myers Squibbs Eliquis) in patients wi...