Food and Drug Administration 1U01FD008948-01

Pathways for Regulatory Innovation and Strategic Modernization (PRISM)

The PRISM project by the Reagan-Udall Foundation supports the FDA's mission through regulatory science, stakeholder engagement, and innovative tools to enhance public health. It focuses on developing regulatory science tools, improving access to FDA-regulated products, and supporting FDA operations through convenings and evaluations.

Description

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 3) Engagements, Convenings, and Operational Evaluations to Support the Work of FDA. Aim 1 emphasizes modern use of real-world data and artificial intelligence, evaluation of data transparency, trust, governance, and the predictive utility of animal studies. 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 food and nutrition research, incentivizing drug development for animals, and rapid response during outbreaks. Aim 3 leverages the Foundation's expertise in convenings—roundtables, expert panels, and public meetings—to support FDA implementation across complex policy areas. 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.

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