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Implement Digital Technologies Carefully: GE HealthCare

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Two medical device stakeholders suggest ways for FDA to regulate generative AI and foundation model-enabled medical devices.

New Copaxone Boxed Warning

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FDA says it is adding a Boxed Warning for anaphylaxis to the labeling for Tevas multiple sclerosis drug Copaxone and its Sandoz ge...

CBER Approved 67 Products in 2024: Report

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CBER director Peter Marks report for 2024 discusses Center approval of 67 products it says integrated advances in science and tech...

FDA Wins Vanda Trade Secret Case

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The U.S. Court of Federal Claims grants FDA summary judgment on the pleadings and rejects Vandas 5th Amendment taking argument abo...

FDA Union Sues Trump Over Schedule F

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The union representing FDA employees sues President Trump over efforts to replace many Civil Service workers with political appoin...

Temporary Embargo on FDA Communications

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The Trump Administration places a temporary embargo on external communications by FDA and other government health agencies until p...

FDA Lifts Hold on Cialis Rx-to-OTC Study

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FDA removes clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it li...

Woodcock Joins Friends of Cancer Research Board

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Patient advocacy group Friends of Cancer Research adds former principal deputy commissioner Janet Woodcock to their board of dire...

FDA Fast Track for Heart Imaging Agent

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FDA grants Life Molecular Imaging a fast track designation to [18F]florbetaben for diagnosing cardiac amyloid light-chain and amyl...

Multiple Incell Violations Cited

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FDA warns San Antonio, TX-based Incell Corp. about CGMP and other issues in its work as a contract manufacturer of a product deriv...