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Senators Want OTC Hearing Aid Regs Issued

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Sens. Grassley and Warren urge FDA to quickly issue over-the-counter hearing aid regulations to implement their bill that was appr...

CDER Compliance Targets 3 Enforcement Areas

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CDER Office of Compliance director Don Ashley tells the Food and Drug Law Institute that his office has been targeting three drug ...

Vaccine Panel Unanimously Supports Moderna Booster

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FDAs Vaccines and Related Biological Products Advisory Committee votes unanimously to support Modernas request for an emergency us...

Califf May Return as FDA Commissioner: Report

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The Washington Post says three sources have indicated the Biden administration is close to bringing former FDA commissioner Robert...

Abbott Molecular Alinity Covid Kit Recall is Class 1

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FDA says the Abbott Molecular recall of two SARS-CoV-2 test kits is Class 1.

FDA Agrees with Consultants on Covid Test EUAs

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FDA agrees with Booz Allen Hamilton recommendations to improve the CDRH effort to issue emergency use authorizations for tests dur...

FDA Wont Enforce ID Submission for Some Class 1 Devices

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FDA says it does not plan to enforce universal device identification submission requirements for some devices it considers to be C...

CDER Emerging Technology Program Expanding

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CDER leaders say they are expanding Center efforts to promote advanced manufacturing techniques for drugs.

FDA Approves Lillys Verzenio Breast Cancer Drug

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FDA approves Lillys Verzenio CDK4/6 inhibitor for certain breast cancer patients as determined by an FDA-approved diagnostic test....

FDA Questions J&J Covid Vaccine Booster Data

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FDA tells its Vaccines and Related Biological Products Advisory Committee it has some concerns about data submitted by J&J in supp...