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FDA General

Califf Comes Down With Covid-19

FDA commissioner Robert Califf tests positive for Covid-19 while traveling over the weekend on agency business.

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Human Drugs

Guide on Bioanalytical Method Validation

FDA posts a final guidance entitled M10 Bioanalytical Method Validation and Study Sample Analysis.

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Human Drugs

Lilly Covid Therapy has Reduced Variant Activity: FDA

FDA updates the Health Care Provider Fact Sheet for Eli Lillys Covid-19 antibody therapy bebtelovimab to highlight expected reduced activity against c...

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Biologics

Guide on Studying Multiple Cell/Gene Therapies

FDA releases a final guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.

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Federal Register

HIV Viral Load Test Down Classified to Class 2

Federal Register notice: FDA issues a final order to reclassify human immunodeficiency virus viral load monitoring tests from Class 3 to Class 2 (spec...

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Federal Register

FDA Revokes 2 Cleveland Clinic Covid EUAs

Federal Register notice: FDA revokes the Emergency Use Authorizations issued to the Cleveland Clinic for two Covid-19 tests.

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Human Drugs

Apellis Pharma NDA Review Extended on New Data

FDA extends by three months its review of an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan based on new data submitted that the agency ha...

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Medical Devices

New MDIC Framework on Device Trials

The Medical Device Innovation Consortium releases a new framework that outlines a systematic approach for patient-focused clinical trial designs.

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Human Drugs

21 State AGs Urge FDA OK of OTC Birth Control

Twenty-one state attorneys general urge FDA to approve over-the-counter birth control pills.

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Medical Devices

Exactechs TriVerse Knee System Cleared

FDA clears an Exactech 510(k) for its TriVerse primary knee system.