Pathways for Regulatory Innovation and Strategic Modernization (PRISM)
openFDA - Food and Drug Administration
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.
Up to $1.3M
health research