Pathways for Regulatory Innovation and Strategic Modernization (PRISM)

The Food and Drug Administration (FDA) is seeking applications for the Pathways for Regulatory Innovation and Strategic Modernization (PRISM) cooperative agreement (RFA-FD-26-007), which supports non-regulatory, science-driven collaborative activities designed to modernize regulatory oversight across FDA-regulated products including medical devices, diagnostics, foods, and digital health solutions. This funding opportunity is exclusively available to the Reagan-Udall Foundation for the Food and Drug Administration as a single-source award and requires applicants to have active registrations in the System for Award Management (SAM), eRA Commons, and Grants.gov prior to submission. Primary objectives include advancing the use of real-world data and artificial intelligence for regulatory science, strengthening patient access pathways to investigational therapies, enhancing transparency in regulatory science, and supporting evidence-based approaches across regulatory domains. Applications will be evaluated using five scored criteria: Significance (10 points), Investigator(s) (10 points), Innovation (30 points), Approach (25 points), and Environment (25 points). The application deadline is April 30, 2026, and the FDA anticipates announcing awards following the submission deadline.

The FDA intends to commit $1,300,000 for fiscal year 2026, with anticipated annual support of $1,300,000 for each of four additional years contingent upon appropriations and satisfactory performance, establishing a potential maximum project period of five years. The cooperative agreement involves substantial programmatic involvement from FDA staff, who will collaborate with the recipient in planning, execution, and evaluation of activities including applied research, stakeholder engagement, convenings, workshops, and tool development. Performance of work will occur at the recipient's institution, with activities spanning multiple FDA-regulated product categories and requiring coordination with diverse stakeholders including patients, consumers, industry representatives, academia, and healthcare workforce members.