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.
FDA accepts for priority review a Kura Oncology NDA for ziftomenib, a potential new treatment for certain adult patients with relapsed or refractory a...
FDA gives de novo authorization to Clarity Breast which uses artificial intelligence to make a five-year breast cancer risk prediction from a screenin...
FDA deputy commissioner for strategic initiatives Lowell M. Zeta adds Special Counsel for FDA role to his duties.
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...
