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.
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FDA posts a draft guidance entitled Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to S...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FDA publishes a draft guidance entitled Transfer of a Premarket Notification (510(k)) Clearance Questions and Answers.
The Government Accountability Office says there are things HHS, FDA, and other units should do to help create a coordinated national approach for diag...
