FDA publishes a draft guidance entitled Transfer of a Premarket Notification (510(k)) Clearance Questions and Answers.
The Government Accountability Office says there are things HHS, FDA, and other units should do to help create a coordinated national approach for diag...
Two former FDA officials add their names to a class-action wrongful termination lawsuit alleging the federal government knowingly used flawed and inac...
Anonymous and named sources raise questions for NBC News about FDAs use of internal AI tools in product reviews and approvals.
FDA commissioner Martin Makary says agency scientists will review the safety of the abortion drug mifepristone based on findings from a study conducte...
FDA commissioner Marty Makary appears to struggle to convey the governments Covid-19 vaccine recommendations in a contentious interview on CBSs Face t...
FDA warns Swedens Rechon Life Sciences about CGMP violations in its production of finished drugs.
FDA warns Chinas Zhejiang Easyclean Daily Chemical Co. about CGMP violations in its production of finished drugs.
