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Califf Sails Through 1st Covid Oversight Hearing

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FDA commissioner Robert Califf easily manages criticisms of the agencys handling of the Covid-19 pandemic during a 2/8 House Energ...

Cell and Tissue Deviations at Palm Beach Fertility Center

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FDA warns the Palm Beach Fertility Center about significant repeat deviations from cellular and tissue regulations.

FDA Criminal Probe Nets Device Maker Indictment

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An FDA Office of Criminal Investigations probe leads to a Puerto Rico federal grand jury indictment against Magnetic Healer and th...

Cell/Gene Therapy Advisory Committee Renewed

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Federal Register notice: FDA announces the renewal of its Cellular, Tissue, and Gene Therapies Advisory Committee for an additiona...

8 Inspection Takeaways from New FDA Law

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Two former FDAers list eight key takeaways from the new FDA Omnibus Reform Act.

OCE Slowed New Projects in 2022

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Oncology Center of Excellence director Richard Pazdur lists five activities for 2023 that build on steps taken in 2022.

Comments on FDA/Patent Office Collaboration

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Four stakeholders respond to the patent offices request for comment on its proposed collaboration with FDA.

Kessler Praises Marks on Covid Response Leadership

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CBER director Peter Marks gets high grades from former FDA commissioner and Biden administration Covid chief science officer David...

Lower Added Benefit Associated with Higher DTC Spend

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Johns Hopkins University researchers say spending on direct-to-consumer ads in 2020 was associated with drugs rated with lower add...

Court Throws Out PhRMA Lawsuit on Drug Importation

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The DC District Court dismisses for lack of standing a Pharmaceutical Research and Manufacturers of America-led lawsuit that sough...