[ Price : $8.95]
A new GAO report finds FDAs regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it face...[ Price : $8.95]
FDA sends AstraZeneca a complete response letter rejecting approval of its BLA for a subcutaneous formulation of Saphnelo (anifrol...[ Price : $8.95]
FDA warns Mexicos Unomedical Device about Quality System and Medical Device Reporting violations in its production of insulin infu...[ Price : $8.95]
FDA warns Abbott Diabetes Care about Quality System violations in its production of glucose monitoring systems at a facility in Al...[ Price : $8.95]
FDA warns the Lake Oswego, OR-based Kirkman drug manufacturing facility about repeat CGMP violations in its production of finished...[ Price : $8.95]
FDA releases the form FDA-483 with 12 observations from an inspection at the Baxter Oncology drug manufacturing facility in Halle,...[ Price : $8.95]
FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submi...[ Price : $8.95]
Rep. Jake Auchincloss calls on FDA to affirm or refute his conclusion that the Commissioners National Priority Voucher program may...