The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.
The grant aims to support the exploration and advancement of digital health technologies (DHTs) like actigraphy, photography, and environmental sensors, in clinical investigations for drug development. It focuses on enabling remote data acquisition to support drug development processes, expanding the ability to capture early signs of chronic diseases, evaluating outcomes in underrepresented populations with unmet medical needs, and improving convenience for trial participants. This funding opportunity encourages partnerships among academia, the biopharmaceutical industry, patient groups, and other stakeholders to advance the use of DHTs in clinical drug development.