On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The publication of this digital health technology (DHT) framework fulfills an FDA commitment under the seventh iteration of the Prescription Drug User Fee Act reauthorization (PDUFA VII). Read the full blog post.
