A new GAO report finds FDAs regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it faces workforce reductio...
FDA warns Abbott Diabetes Care about Quality System violations in its production of glucose monitoring systems at a facility in Alameda, CA.
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...
An FDA-authored journal article signals a supportive but cautious regulatory posture toward the development of chimeric antigen receptor T-cell therap...
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.
HHS Office of Inspector General begins an ethics investigation into FDA deputy chief of staff Samuel Doran and whether he misled the federal governmen...
FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
