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Vaccine Panel Unanimously Supports Moderna Booster

[ Price : $8.95]

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...

Keytruda Plus Chemo Approved for Cervical Cancer

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FDA approves Mercks Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for patients with pers...

Some Class 1 Devices Exempt from UDI

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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Unique Device Identification: Policy Reg...