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FDA Panel Backs Novavax Covid-19 Vaccine

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An FDA Advisory Committee votes unanimously (21 to 0) to recommend that the agency grant Novavax an emergency use authorization fo...

CDRH Reg Advisor Silverstein Joins Private Sector

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CDRH Office of Device Evaluation regulatory advisor Joshua Silverstein leaves FDA for an undisclosed private sector job.

CGMP, Other Violations at Aire-Master of America

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FDA warns Nixa, MO-based Aire-Master of America about CGMP and other violations in its manufacturing of two hand sanitizers.

Shuren Advocates for More Regulatory Flexibility Post Covid

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CDRH director Jeff Shuren says that life after Covid-19 at the Center could greatly benefit from more regulatory flexibility, whic...

FDA Approves GSKs Measles Vaccine

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FDA approves a GSK BLA for Priorix (measles, mumps and rubella vaccine) for use in individuals 12 months of age and older.

Bristol Myers Withdraws sBLA for Reblozyl

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Bristol Myers Squibb withdraws a supplemental BLA for Reblozyl (luspatercept-aamt) for treating anemia in adults with non-transfus...

WA State Court Backs Learned Intermediary in DTC Case

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The Washington State Supreme Court rules that doctors, and not drug companies, bear responsibility to warn patients about potentia...

Class 1 Recall on Respironics Ventilators with Faulty Alarms

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FDA classifies as Class 1 a Philips Respironics recall of all V60 and V60 Plus ventilators because an internal power fluctuation m...

Guide on Device Meetings/User Fee Submissions Withdrawn

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Federal Register notice: FDA withdraws its guidance entitled Effects of the Covid-19 Public Health Emergency on Formal Meetings an...

Complete Response Letters Not for Judicial Review: Court

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An appeals court rules that it does not have jurisdiction to hear disputes arising from FDA complete response letters because they...