Merck and Daiichi Sankyo say their HERTHENA-Lung02 Phase 3 trial evaluating patritumab deruxtecan in certain patients with locally advanced non-small ...
Federal Register notice: FDA announces an 11/20-21 Digital Health Advisory Committee meeting to discuss generative artificial intelligence-enabled dev...
Federal Register notice: FDA makes available a draft guidance entitled Considerations for Generating Clinical Evidence From Oncology Multiregional Cli...
Federal Register notice: FDA classifies quantitative viral nucleic acid tests for transplant patient management into Class 2 (special controls).
FDA publishes a guidance on integrating clinical trials into routine clinical practice.
FDA issues a safety alert about an increased risk of thigh bone fracture after surgery with the use of the Zimmer Biomet CPT Hip System Femoral Stem 1...
FDA issues SSM St. Clare Health Center a 10-observation Form FDA-483 for GMP deficiencies found during an inspection at an outsourcing facility in Fen...
FDA posts a draft guidance entitled Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs (CDP).
