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- FDA’s Biologics Branch Scores Wins Against Unproven Stem Cell Clinics, Says ExpertProfessor Paul Knoepfler, a cell‑biology professor at UC Davis, writes that the FDA’s biologics division has recently taken concrete steps to curb the proliferation of unproven stem‑cell clinics in…
- 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…