California, Massachusetts, New Jersey, and New York ask FDA to cancel the mifepristone REMS program requirements in their states or decline to enforce...
FDA commissioner Marty Makary promises that the agency will listen to stakeholder ideas on reducing regulatory barriers and evolving its processes by ...
FDA announces three Class 1 recalls (device corrections) by Smiths Medical related to certain CADD [computerized ambulatory delivery device]-Solis Amb...
FDA warns Chinas Huangshi Hygienec Material Medicine Co. about CGMP violations in its manufacturing of finished drugs.
Vigil Neuroscience ends its Phase 2 long-term extension study of investigational therapy iluzanebart based on disappointing study results.
FDA posts a draft guidance entitled Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to S...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FDA publishes a draft guidance entitled Transfer of a Premarket Notification (510(k)) Clearance Questions and Answers.
