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FDA’s Digital Leap: What are the Latest Digital Health Updates from the Agency?

FDA is heading into October after releasing several landmark program and guidance updates that show progress in implementing the agency’s Digital Health Innovation Action Plan and promise for the field of digital health as a whole. These updates came amidst a push in Washington to reauthorize PDUFA legislation, which contains several provisions that impact digital health, including a plan to produce a cross-FDA framework to guide the generation and use of digitally-derived data for regulatory decision-making.



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