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Three Epstein Becker Green attorneys analyze a new FDA draft guidance on communicating scientific information on unapproved uses o...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

FDA Warns on Monoject Syringes

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FDA warns healthcare professionals not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesi...

Janssen Seeks Expanded Rybrevant Use

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Janssen Pharmaceutical files a supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin and...

Dr. Reddys Issued 10-item FDA-483

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FDA issues Dr. Reddys Laboratories a 10-item Form FDA-483 after an inspection 10/27 at the firms Telangana, India manufacturing fa...