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- FDA asks industry input on competency-based rules for generative AI medical devicesThe FDA announced it is soliciting comments on a proposed competency-based framework for overseeing medical devices that incorporate generative artificial intelligence. The agency says the approac…
- FDA pushes back PDUFA date for Capricor's Duchenne therapy to review new dataThe U.S. Food and Drug Administration announced it has extended the PDUFA target date for Capricor Therapeutics' investigational Duchenne muscular dystrophy treatment. The agency said the extensio…