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FDA Safety Notices Can Affect Liability: Analysis

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Two Hyman, Phelps & McNamara attorneys caution that actions providers take in response to an FDA safety communication could be see...

Feds Interested in FDA-based False Claims Cases: Attorneys

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Covington attorneys say the Justice Department has signaled it remains interested in pursuing False Claims Act cases premised on v...

Celltrion Gains Avastin Biosimilar Approval

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FDA approves a Celltrion BLA for Vegzelma (bevacizumab-adcd), a biosimilar to Genentechs Avastin (bevacizumab), for treating six c...

Eisai/Biogen Claim Lecanemab Trial Success

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Eisai and Biogen tout the highly significant confirmatory Phase 3 trial results of their investigational Alzheimers drug lecanemab...

Guide on Clinical Decision Support Software

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Federal Register notice: FDA makes available a final guidance entitled Clinical Decision Support Software.

Oncologic Surrogates Rarely Correlate with Survival: Study

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University of California San Francisco researchers say only one of 15 oncologic drug surrogate analyses conducted by FDA showed a ...

FDA Mobile Medical App Software Policy

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FDA publishes a guidance on how it will exercise oversight over select software functions in mobile and general purpose computing ...

FDA, VA Collaborate to Accelerate Device Innovation

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FDA announces a collaborative effort with the Veterans Health Administration to speed medical device innovation by developing new ...

Partial Hold on Avidity Bio Therapy

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FDA issues Avidity Biosciences a partial clinical hold on new participant enrollment in its Phase 1/2 MARINA clinical trial of AOC...

Comments on Drug Interaction Study Guidance

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Two stakeholders give FDA technical comments on a guidance based on an International Council for Harmonization guideline on drug i...