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- FDA launches TEMPO pilot to let generative AI medical devices reach patients before formal approvalThe Food and Drug Administration has opened a new pilot program called TEMPO that permits certain generative‑AI medical devices to be made available to patients even though they have not received f…
- FDA advisory panels for Capricor and Replimune highlight need for rare-disease specialist inputRecent FDA advisory committee meetings reviewing therapies from Capricor Therapeutics and Replimune produced markedly different outcomes, underscoring how the agency’s reliance on specialist input…