Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional
Closed Posted
- Opportunity number
- RFA-FD-26-012
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Applications due
- Award size
- Up to $1,100,000
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Categories
-
- Agriculture
- Consumer Protection
- Food and Nutrition
- Eligible applicants
-
- Tribal Governments (Federally Recognized)
- 501(c)(3) Nonprofits
- Public or Indian Housing Auth.
- Independent School Districts
- City/Township Governments
- Tribal Organizations (Not Federally Recognized)
- State Governments
- Higher Education Inst. (Public)
- County Governments
- Special District Governments
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Private)
- Small Businesses
- For Profit Organizations
Opportunity details come from Grants.gov. Updated .
About this opportunity
The Food and Drug Administration is soliciting applications for cooperative agreements supporting research on digital health technologies in clinical investigations to support drug and biological product development, with applications due August 20, 2026. Up to $2.2 million is available to fund up to 2 awards, each capped at $1.1 million per year for up to 2 years; no cost share is required.
Eligible applicants include higher education institutions (public and private), 501(c)(3) and non-501(c)(3) nonprofits, state and local governments, tribal governments and organizations, small businesses, for-profit organizations, and special district governments. Foreign organizations are not eligible. The program accepts new applications only, with an optional clinical trial component.
Projects must address topics including comparing digital measurements to traditional clinical trial measurements, developing novel digital health technology-based endpoints for drug trials, evaluating continuous measurements, and capturing early disease manifestations using digital technologies in populations with unmet medical needs. Applications must include a Data Management and Sharing Plan and comply with cybersecurity requirements, IRB approval, and ClinicalTrials.gov registration where applicable.
The FDA will conduct objective review using scored criteria (Significance, Investigator(s), Innovation, Approach, and Environment) on a 100-point scale. The agency will provide substantial programmatic involvement as a cooperative partner, including subject-matter expertise decision-making at project milestones and review of study protocols. Eligible PD/PIs must be established investigators capable of providing administrative and scientific leadership.
This opportunity is assigned to CFDA 93.103 (Food and Drug Administration Research) and administered by the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research under Activity Code U01.
Synopsis
The purpose of this Notice of Funding Opportunity (NOFO) is to address topics related to the use of digital health technologies (DHTs) for remote data acquisition in clinical investigations to support drug development.
Files
| File | Type | Posted |
|---|---|---|
| RFA-FD-26-012.pdf | ||
| RFA-FD-26-012.pdf |
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