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Guide on Studying Multiple Cell/Gene Therapies

[ Price : $8.95]

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

HIV Viral Load Test Down Classified to Class 2

[ Price : $8.95]

Federal Register notice: FDA issues a final order to reclassify human immunodeficiency virus viral load monitoring tests from Clas...

FDA Revokes 2 Cleveland Clinic Covid EUAs

[ Price : $8.95]

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

Apellis Pharma NDA Review Extended on New Data

[ Price : $8.95]

FDA extends by three months its review of an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan based on new data submitte...

New MDIC Framework on Device Trials

[ Price : $8.95]

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

21 State AGs Urge FDA OK of OTC Birth Control

[ Price : $8.95]

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

Exactechs TriVerse Knee System Cleared

[ Price : $8.95]

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

Guide on Bioanalytical Method Validation

[ Price : $8.95]

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

Lilly Covid Therapy has Reduced Variant Activity: FDA

[ Price : $8.95]

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

Lifting Barriers to Transgender People in Cancer Trials

[ Price : $8.95]

FDA and academic researchers present a framework to include transgender people in clinical trials.