That @U.S. FDA is recognizing here the urgent need for regulatory strategies to evolve to match the pace of scientific advances in ways that streamline bringing the science safely to patients is incredibly important. I hope these new policies provide a foundation that will eventually allow certain kinds of genetic surgeries to become as routine as life-saving conventional surgeries, in which the process is robust and standardized enough to be rapidly adapted to each patient, without the need for a separate multi-year regulatory process for each surgery.

NEJM

@NEJM

Nov 12 25

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Personalized therapies hold tremendous promise but challenge traditional models of drug and biologic development. The @U.S. FDA outlines a path to market entry for products where a randomized trial is not feasible. Learn more: https://nej.md/4nUQdcl

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