Former CDRH branch chief Morris Waxler, who was involved in the original approval of laser eye surgery (LASIK) and later a prominent critic of the pro...
A new GAO report finds FDAs regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it faces workforce reductio...
FDA sends AstraZeneca a complete response letter rejecting approval of its BLA for a subcutaneous formulation of Saphnelo (anifrolumab) for treating a...
FDA warns Mexicos Unomedical Device about Quality System and Medical Device Reporting violations in its production of insulin infusion sets.
FDA warns Abbott Diabetes Care about Quality System violations in its production of glucose monitoring systems at a facility in Alameda, CA.
FDA warns the Lake Oswego, OR-based Kirkman drug manufacturing facility about repeat CGMP violations in its production of finished drugs.
FDA releases the form FDA-483 with 12 observations from an inspection at the Baxter Oncology drug manufacturing facility in Halle, Germany.
FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
