WASHINGTON, March 31 -- Food and Drug Administration has issued a notice called: Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments.
The notice was published in the Federal Register on March 31 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: Digital health technologies (DHTs) used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research. As outlined in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VII) included as part of the FDA User Fee Reauthorization Act of 2022, the Center for Drug Evaluation an...