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FDA releases a final guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical...[ Price : $8.95]
Federal Register notice: FDA issues a final order to reclassify human immunodeficiency virus viral load monitoring tests from Clas...[ Price : $8.95]
Federal Register notice: FDA revokes the Emergency Use Authorizations issued to the Cleveland Clinic for two Covid-19 tests.[ Price : $8.95]
FDA extends by three months its review of an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan based on new data submitte...[ Price : $8.95]
The Medical Device Innovation Consortium releases a new framework that outlines a systematic approach for patient-focused clinical...[ Price : $8.95]
Twenty-one state attorneys general urge FDA to approve over-the-counter birth control pills.[ Price : $8.95]
FDA clears an Exactech 510(k) for its TriVerse primary knee system.[ Price : $8.95]
FDA posts a final guidance entitled M10 Bioanalytical Method Validation and Study Sample Analysis.