Simpler Grants.gov #RFA-FD-26-012

FDA Funding for Research on Digital Health Technologies in Clinical Investigations

This opportunity is a funding program from the U.S. Food and Drug Administration (FDA), under the Department of Health and Human Services, specifically managed by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). - The FDA seeks research projects that advance the use of digital health technologies (DHTs) in clinical drug and biological product development. - Technologies of interest include actigraphy, photography, and contactless sensors for remote data acquisition. - Key project areas include: - Comparing digital health measurements to traditional clinical measurements - Developing novel clinical trial endpoints using DHTs - Evaluating continuous measurements and capturing early manifestations of chronic diseases - The funding instrument is a cooperative agreement (U01), with up to $2.2 million available for up to two awards, each supporting up to two years of research. - No specific OEMs or vendors are named; the focus is on research and development, not procurement of particular products. - Eligible applicants include government, nonprofit, educational, and business entities. - Notable requirements: - Projects must comply with FDA-specific application instructions and data management plans.

Description

This Notice of Funding Opportunity (NOFO) from the Food and Drug Administration aims to support projects related to the use of digital health technologies (DHTs) for remote data acquisition in clinical investigations to aid drug development. The goal is to explore the role of DHTs in drug development, including comparing digital measurements to traditional ones, developing novel endpoints, evaluating continuous measurements, and capturing early manifestations of chronic diseases. The funding supports cooperative agreements with optional clinical trials and encourages collaboration among academia, industry, patient groups, and other stakeholders. The award provides up to $1,100,000 per year for up to two years, with an anticipated two awards.

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