In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” This framework goes part of the way in satisfying the FDA’s commitments promised under the PDUFA VII and addresses a few important challenges associated with the use of DHTs in drug, device, and biologics product development. Here is what you need to know.
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