FDA RFA-FD-26-012 | Digital Health Technologies for Drug Development Funding (U01)
Quick Answer:
FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are jointly funding a U01 Research Project Cooperative Agreement focused on using digital health technologies (DHTs) — actigraphy, photography, contactless sensors — for remote data acquisition in drug and biologic clinical trials. CDER intends to fund up to 2 awards, totaling $2.2 million in FY2026, with each award providing up to $1.1M/year across a 2-year project period. Unlike a standard SBIR, this is a cooperative agreement, meaning FDA scientific staff will be substantially involved in protocol review and study design throughout the project.
Applications are due August 20, 2026, by 11:59 PM local time.
What Does This Opportunity Fund?
Four illustrative (non-exclusive) project types:
Comparing digital measurements to traditional clinical trial measurements
Developing novel DHT-based endpoints for unmet drug development needs (e.g., contactless sensors detecting pediatric apnea)
Comparing continuous measurement metrics (e.g., activity/stamina)
Capturing early manifestations of chronic disease through DHTs (e.g., balance or reaction-time testing for early dementia signs)
What Makes This Different From a Standard NOFO?
Cooperative agreement (not a grant) — FDA retains substantial programmatic involvement, including protocol review at milestones
Clinical Trial Optional — applicants can propose a trial or non-trial project
Applies to drugs/biologics only, not devices
Research Strategy section capped at 12 pages (FDA does not follow standard NIH page limits)
How Is It Reviewed?
Standard FDA Objective Review Process, scored across five weighted criteria:
Significance (20 pts)
Investigator(s) (20 pts)
Innovation (25 pts)
Approach (25 pts)
Environment (10 pts)
Who Is Eligible?
Broad eligibility — universities, nonprofits, small businesses, other for-profits, and eligible government entities. Foreign organizations and foreign components are not eligible. No cost-sharing required. Multiple applications allowed if scientifically distinct.
Key Dates
Posted: July 20, 2026
Open Date: July 20, 2026
Application Due: August 20, 2026
Expiration: August 21, 2026
How Can BW&CO Help?
This is a cooperative agreement, not a typical grant — framing the Research Strategy to anticipate FDA's ongoing programmatic involvement (not just initial review) is critical. Our approach helps clients position DHT-based endpoints and study designs that align with FDA's DHT Framework priorities from the outset.
