Pathways for Regulatory Innovation and Strategic Modernization (PRISM)

About This Grant

Effective engagement with the public is essential to expand the impact of the U.S. Food and Drug Administration, and for the efficient transfer of information and insights among the Agency, patients, academia, consumers, healthcare, and regulated industry. Through PRISM: Pathways for Regulatory Innovation and Strategic Modernization, the Reagan-Udall Foundation for the FDA proposes a multi-year effort to support the FDA's mission to protect and promote the public's health. As a Congressionally chartered, independent nonprofit, the Foundation serves as a neutral bridge between FDA and diverse stakeholders, delivering applied regulatory science, real-world insights, and transparent engagement. The Foundation does not participate in regulatory decision-making. Building on more than 70 collaborative projects completed between 2020 and 2025, the PRISM project portfolio advances FDA priorities through three Specific Aims: 1) Support the Development and Use of Regulatory Science Tools, 2) Support Programs and Research to Enhance Development of and Access to FDA-Regulated Products, and 3) Engagements, Convenings, and Operational Evaluations to Support the Work of FDA. Aim 1 strengthens regulatory science tools, with emphasis on modern use of real-world data and artificial intelligence, evaluation of data transparency, trust, and governance, and assessment of the predictive utility of animal studies to support efforts to reduce animal testing. Aim 2 focuses on improving development of and access to FDA-regulated products by expanding patient- and consumer-centered initiatives, enabling access to investigational new drugs, studying appropriate use of controlled substances, supporting gold-standard food and nutrition research, incentivizing drug development for animals, and assisting rapid response collaboration during cross-sectoral outbreaks. Aim 3 leverages the Foundation's expertise in convenings—roundtables, expert panels, and public meetings—to support FDA implementation across complex policy areas, including drug development, cosmetics oversight, rare diseases, food safety, mental health, and counterfeit products. Projects are jointly designed with FDA staff, delivered on defined timelines and budgets, and culminate in public outputs to promote learning, transparency, trust, and impact. Collectively, through PRISM, the Foundation provides FDA with timely evidence, stakeholder insight, and practical tools to modernize regulatory science and address emerging public health challenges efficiently, transparently, and in a trustworthy manner.