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FDA commissioner Robert Califf discusses improved research and technology development, combined with general advances in biologica...[ Price : $8.95]
FDA issues Alexion Pharmaceutical a three-item Form-483 after inspecting its Smithfield, RI manufacturing facility.[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a survey of al...[ Price : $8.95]
Federal Register Notice: FDA determines that nine drug products were not withdrawn for reasons of safety or effectiveness.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Ulcerative Colitis: Clinical Trial Endpoints.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Deciding When to Submit a 510(k) for a Software Change to an Existing Devi...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device.[ Price : $8.95]
Federal Register Notice: FDA reopens the comment period on the potential user-fee program for nonprescription drugs and plans a We...