Pathways for Regulatory Innovation and Strategic Modernization (PRISM)

The U.S. Food and Drug Administration (FDA) has announced a funding opportunity through its Pathways for Regulatory Innovation and Strategic Modernization (PRISM) program, under the cooperative agreement RFA-FD-26-007. Administered by the FDA’s various centers and offices—including the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and others—this initiative aims to strengthen the scientific, collaborative, and operational foundations necessary to modernize regulatory oversight in an evolving public health landscape. Rapid advancements in medical products, food safety, diagnostics, digital health, and data science demand a regulatory system that can adapt to these innovations to ensure the safety, efficacy, and quality of FDA-regulated products. The PRISM program focuses on forward-looking, non-regulatory collaboration that aligns with the FDA Commissioner’s strategic priorities. It seeks to bridge gaps between innovation and regulation through stakeholder engagement, applied research, and the development of scientific tools. The initiative will support convenings, dissemination of best practices, and the generation of real-world evidence and data to improve regulatory predictability and transparency. Key areas of focus include the integration of real-world data (RWD) and artificial intelligence, improved access to investigational therapies, enhancement of public trust in regulatory science, and the advancement of gold-standard science in food safety and nutrition. PRISM supports a wide range of activities designed to foster engagement with patients, industry, academia, and other stakeholders. These activities include public forums, applied methodological research, data analysis, and the creation of frameworks and tools that improve regulatory clarity. It will also focus on streamlining expanded access pathways for patients and providers, addressing operational barriers, and building public understanding of the FDA’s regulatory approaches. One additional area of interest includes fostering domestic innovation and competition, especially in early-stage clinical development. The funding instrument is a cooperative agreement, meaning that the FDA will maintain substantial involvement throughout the award period. The total anticipated funding is $1.3 million per year, with a maximum project period of five years. Only one award is expected to be made, with a total ceiling of $6.5 million over the full period. The grant does not require cost sharing or matching funds. Applications should align with FDA public health goals and clearly demonstrate the capacity to generate high-quality, reproducible evidence across regulatory domains. The only eligible applicant for this single-source funding opportunity is the Reagan-Udall Foundation for the Food and Drug Administration. Foreign entities and components are not eligible to apply. Applications must be submitted via Grants.gov or ASSIST by April 30, 2026, 11:59 PM local time. There are no pre-application requirements such as Letters of Intent or Concept Papers. All standard registration requirements (SAM, UEI, eRA Commons) must be met prior to submission. Late applications will not be accepted. Evaluation criteria will focus on significance, investigator qualifications, innovation, approach, and environment, with separate consideration given to human subjects protections and budget justification. Awards will be announced following scientific review and internal FDA funding decisions. The award period begins in fiscal year 2026, and applications open on March 31, 2026. Although the PRISM program is anticipated to be recurring, this specific funding opportunity expires on May 1, 2026, and includes no automatic renewals or resubmission pathways.