Reagan-Udall Foundation

What Reagan-Udall Foundation does

The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) non-profit organization created by Congress in 2007 to advance the U.S. Food and Drug Administration's regulatory science mission. Headquartered in Washington, D.C., with 11-50 employees, the Foundation operates as a neutral convener and research intermediary between the FDA, regulated industries, academic researchers, healthcare providers, and patient communities. Its work focuses on modernizing product development, accelerating medical innovation, and enhancing safety across drugs, biologics, food, and veterinary products.

The Foundation's portfolio is organized around discrete program areas rather than a unified commercial product. Core tools include the Expanded Access eRequest application and Navigator, which walk physicians and patients step-by-step through the expanded access process for investigational treatments, and the COVID-19 Hub, a centralized public-information resource launched in 2020 in collaboration with FDA's Center for Biologics Evaluation and Research. Research infrastructure centers on IMEDS (Innovation in Medical Evidence Development and Surveillance), providing real-world evidence across more than 110 million people, the Regulatory Science Accelerator for computational modeling and simulation of FDA-regulated products, and targeted programs on substance use disorders (RAISE), rare disease innovation, oncology multi-regional clinical trials, and post-market research. The Foundation also convenes recurring industry roundtables on food traceability, healthy labeling, nutrition incentives, and drug repurposing, and runs the Fellowship in Regulatory Science Innovation to train the next generation of regulatory professionals.

The Foundation does not charge for its public resources, publications, or most services. Revenue is not publicly disclosed, but its operations are sustained by a mix of congressionally authorized status, industry co-funding of specific convenings (e.g., nutrition roundtables funded by Ahold Delhaize USA and H-E-B), and grants supporting individual research programs. Customer-facing activity spans FDA program centers, biopharmaceutical companies, food industry stakeholders, healthcare providers, and patient advocacy organizations, with the FDA acting as both the primary strategic partner and the principal mandate-setter.

Name

Reagan-Udall Foundation

Legal name

Reagan-Udall Foundation for the FDA

Website

https://reaganudall.org

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

The Reagan-Udall Foundation is a Congressionally chartered 501(c)(3) non-profit that serves as an independent convener and research partner for the FDA, advancing regulatory science across drugs, food, and veterinary products. It connects FDA, industry, academia, providers, and patients through tools, research programs, and stakeholder roundtables.

Ownership category

akta.pro rank

Product category

Regulatory Science Research

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)

akta.pro secondary industry

Clinical Trials Authorization & Oversight (GCP) (HLAJADAF)

Keywords

• Regulatory science research
• FDA stakeholder convening
• Expanded access navigation
• Real-world evidence research
• Food safety policy

Headquarters

HQ city

Washington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Others, Marketing or Sales, Technology or R&D

Distribution channels2 records

Marketing channels4 records

Core offering

The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) non-profit created by Congress to advance regulatory science and support the FDA's mission of modernizing product development, accelerating innovation, and enhancing product safety. It delivers a portfolio of public-facing tools (Expanded Access eRequest app and Navigator), research programs (IMEDS real-world evidence, Regulatory Science Accelerator, Real World Data, RAISE), stakeholder convenings (rare disease, oncology clinical trials, food traceability, healthy claim roundtables), and educational resources on FDA-regulated products for healthcare providers, patients, industry, and FDA itself.

Product overview

The Reagan-Udall Foundation is a non-profit foundation that serves as a convening organization to advance the FDA's mission of modernizing product development, accelerating innovation, and enhancing product safety. Rather than offering a unified commercial software product, the Foundation provides a portfolio of public-facing tools, research programs, and stakeholder convening initiatives. Key products include the Expanded Access eRequest app and Navigator, which help physicians and patients navigate the expanded access process; the COVID-19 Hub providing centralized COVID-19 information; and the IMEDS research program delivering real-world evidence on healthcare. The Foundation operates through multiple program areas including Food & Nutrition, Regulatory Science, Substance Use Disorders, and Rare Disease Innovation, offering publications, roundtables, educational resources, and engagement platforms rather than traditional commercial products.

Differentiator

Problem solved

Functional benefit

Brands

• Expanded Access eRequest: An online tool that walks physicians and healthcare providers step-by-step through the expanded access process.
• Navigator
• COVID-19 Hub
• COVID-19 Vaccine Confidence Project
• IMEDS
• Real World Data
• RAISE
• Regulatory Science Accelerator

Products and services

• Expanded Access eRequest Online application that walks physicians and healthcare providers step-by-step through the expanded access process for obtaining investigational treatments for patients.
• Expanded Access Navigator Comprehensive resource and tool helping patients, providers, and consumers navigate the expanded access process for investigational treatments.
• COVID-19 Hub Centralized resource providing science-based information on COVID-19 regarding medical response, food and veterinary safety, clinical trials, and vaccine confidence.
• IMEDS (Innovation in Medical Evidence Development and Surveillance) Research program providing real-world insight into the healthcare experience of more than 110 million people, focusing on medical evidence development and post-market surveillance.
• Regulatory Science Accelerator Computational modeling and simulation initiative supporting innovation in regulatory science for FDA-regulated products.
• Food & Nutrition Programs Multiple initiatives supporting FDA's Nutrition Innovation Strategy, including food traceability, healthy claim roundtables, nutrition communications, and produce safety dialogue.
• Substance Use Disorders Research (RAISE Program) Research and analysis programs addressing substance use disorders, supporting evidence-based approaches to addiction and treatment.
• Real World Data Program Research initiatives leveraging real-world data to assess the long-term impact of FDA food-related regulations and policies.
• Rare Disease Innovation Roundtable Stakeholder roundtable focused on advancing innovation for rare disease treatments and regulatory approaches.
• Oncology Multi-Regional Clinical Trials Initiative Initiative to improve the design and conduct of oncology clinical trials across multiple regions.
• COVID-19 Vaccine Confidence Project Project providing information to address COVID-19 vaccine hesitancy by explaining the vaccine development process, safety, and FDA's role in review and authorization.
• Fellowship in Regulatory Science Innovation Fellowship program designed to train the next generation of regulatory science professionals.

Quantifiable outcome

• IMEDS research portfolio covers healthcare experience of more than 110 million people

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered core and minor.

• U.S. Food and Drug Administration (FDA)coreStrategic or Co-development PartnerPrimary partner in advancing FDA's regulatory science mission. Collaborates on initiatives including drug repurposing frameworks, food safety rules, nutrition policy, and COVID-19 response. The Foundation convenes meetings and develops recommendations in collaboration with FDA programs including the Center for Biologics Evaluation and Research.
• Palvella TherapeuticsminorGTM or Marketing PartnerSelected to provide public comment at an FDA public meeting on drug repurposing criteria and prioritization, demonstrating the Foundation's role in facilitating industry engagement with FDA regulatory processes.
• FDA Center for Biologics Evaluation and ResearchcoreStrategic or Co-development PartnerCollaborated with the Foundation on the COVID-19 Vaccine Confidence Project to better understand perceptions leading to vaccine hesitancy and identify credible messages and messengers.

Scale indicators1 record

Recent moves6 records

Expansion highlights5 records

Regional players

• Biotechnology Innovation Organization (BIO): Industry trade association that engages with FDA on regulatory policy and represents biopharmaceutical companies. Adjacent to the Foundation's industry-convening role but represents commercial members rather than serving as neutral convener.

Broad incumbents

• Drug Information Association (DIA): Global professional association for regulatory science and drug development, convening industry, regulators, and academia. Comparable neutral-convener role across the regulatory ecosystem.
• National Academies of Sciences, Engineering, and Medicine: Congressionally-chartered institution that produces consensus reports on FDA-regulated topics including drug safety, nutrition, and food policy. Comparable federally-sanctioned research and convening authority.
• Duke-Margolis Center for Health Policy: University-affiliated policy center producing FDA-relevant regulatory science research and convening stakeholders on drug development, real-world evidence, and value-based care. Comparable research-and-convening mandate.

Direct peers

• Critical Path Institute: Independent non-profit that collaborates with FDA on regulatory science, drug development tools, and data-driven methodologies. Highly comparable in mission, structure, and FDA-relationship model.
• FasterCures (Milken Institute): Non-profit focused on accelerating medical research and patient access to treatments through stakeholder engagement and policy work. Operates similar convening and patient access functions.
• Friends of Cancer Research: Non-profit policy advocacy organization that drives regulatory innovation and partners with FDA on cancer drug development frameworks. Comparable convening role and FDA collaboration model.
• Patient-Centered Outcomes Research Institute (PCORI): Independent non-profit research organization funded through Congress that funds comparative clinical effectiveness research and convenes stakeholders. Comparable congressional mandate and patient-outcomes focus.

Emerging players

• National Patient Advocate Foundation: Non-profit patient advocacy organization engaging with FDA on expanded access, clinical trials, and patient engagement. Comparable focus on patient access and FDA patient listening initiatives.
• ClinicalTrials.gov (NIH/NLM): Government public resource for clinical trial registration and results reporting, addressing patient/provider access to trial information. Comparable public-information infrastructure function for FDA-regulated products.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/ruf_fda
• YouTubeyoutube.com/channel/UCDiM1-Jm1BHwULxF_zPuBMQ
• Facebookfacebook.com/reaganudall/?ref=ts&fref=ts
• LinkedInlinkedin.com/company/reagan-udall-foundation-for-the-fda

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Reagan-Udall Foundation