FDA posts a draft guidance entitled Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to S...
FDA warns Medley, FL-based Evi Labs about CGMP violations in its work as a contract drug manufacturer.
FDA publishes a draft guidance entitled Transfer of a Premarket Notification (510(k)) Clearance Questions and Answers.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 warns Koreas DFI Co., Ltd. about Quality System and Medical Device Reporting violations in its manufacturing of reagent strips.
Three Morgan Lewis attorneys tell regulated product sponsors to watch for AI involvement in FDA reviews and be prepared to respond when necessary.
