Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional

This Notice of Funding Opportunity (NOFO), issued by the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER), announces a cooperative agreement program (RFA-FD-26-012) to explore the use of Digital Health Technologies (DHTs) for remote data acquisition in clinical investigations to support drug and biological product development. The program aims to advance the integration of DHTs—such as actigraphy, photography, and contactless sensors—into drug development. Focus areas include comparing digital and traditional measurements, developing novel clinical endpoints, evaluating continuous measurements, and capturing early manifestations of chronic diseases. CDER intends to commit up to $2.2 million in FY 2026 to fund up to two awards. Each cooperative agreement provides up to $1.1 million in total costs (direct and indirect) per year for a maximum project period of two years, subject to annual appropriations and recipient performance. Eligible applicants include higher education institutions, nonprofits, for-profit organizations (including small businesses), and state, local, or tribal governments. Non-domestic (foreign) organizations and foreign components are not eligible. Applications must be submitted electronically via Grants.gov by August 20, 2026. As cooperative agreements, projects will involve substantial joint scientific and programmatic collaboration between the recipient’s Principal Investigator and FDA subject-matter experts. Applications will be evaluated through the FDA's objective review process based on significance, investigator credentials, innovation, approach, and scientific environment.