FDA posts a draft guidance entitled Hernia Mesh Package Labeling Recommendations.
FDA confirms that all drugs now have updated labeling to better provide health risk information to pregnant women.
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 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.
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.
