Framework for the Use of Digital Health Technologies in Drug and Biological Product Development; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the publication of a digital health technology (DHT) framework by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. This framework is entitled "Framework for the Use of Digital Health Technologies in Drug and Biological Product Development." This fulfills an FDA commitment under the seventh iteration of the Prescription Drug User Fee Act (PDUFA VII) reauthorization, incorporated as part of the FDA User Fee Reauthorization Act of 2022.