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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…
- Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapiesIndustry groups have asked the U.S. Food and Drug Administration to broaden its draft guidance on the use of scientifically valid prior knowledge in developing gene therapies that involve genome ed…