Reagan-Udall Foundation for the FDA

11/13/2025

Learn more about the Navigator and eRequest app — the Foundation’s programs to help patients access investigational drugs — to see if Expanded Access may be an option for you or a loved one: https://navigator.reaganudall.org

11/11/2025

On this , we thank all who have served our country. Today, we salute you.

11/10/2025

We're pleased to announce the release of our Infant Formula Roundtable Series: Report on Cross-sector Stakeholder Insights.

This report summarizes discussions from a September 2025 roundtable series that brought together stakeholders to explore ways to strengthen the safety, quality, nutrition, and resiliency of infant formula products in the U.S.

Priority areas include:
- Comprehensive Nutrient Review
- Heavy Metals and Contaminants
- Labeling and Marketing Claims

Read the full summary report: https://reaganudall.org/publications/infant-formula-roundtable-series-report-cross-sector-stakeholder-insights

11/07/2025

Our summary of the 2025 Online Controlled Substances Summit, convened in collaboration with the U.S. Food and Drug Administration, is now available!

Read the report, highlighting emerging challenges, innovative approaches, and collaborative efforts aimed at addressing this complex and evolving public health concern: https://reaganudall.org/publications/2025-online-controlled-substances-summit-meeting-summary-report

11/06/2025

2025 Advocacy/Policy Award Honoree Spinal Muscular Atrophy Foundation President Loren A. Eng's visionary, patient led advocacy has reshaped rare disease policy, accelerated U.S. Food and Drug Administration approvals for Spinal Muscular Atrophy therapies, and set a new standard for how advocacy can drive regulatory science.

Learn more about our 2025 Honorees: https://reaganudall.org/news-and-events/awards/innovations-regulatory-science-policy-awards

11/04/2025

Multi-regional clinical trials are increasingly critical to oncology drug development—but challenges such as lengthy site activation, slow patient enrollment, and regional variability continue to hinder progress.

To help address these barriers, the Foundation convened an expert roundtable to identify realistic and impactful solutions for sponsors, clinical sites, regulators, and patient advocates.

Our new report, Improving Oncology Multi-Regional Clinical Trials, offers actionable recommendations to improve trial clarity, consistency, and efficiency.

Read the full report: https://reaganudall.org/publications/improving-oncology-multi-regional-clinical-trials

11/03/2025

Download the "Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population: Public Meeting Summary Report." https://reaganudall.org/publications/use-orally-ingestible-unapproved-prescription-drug-products-containing-fluoride

Today, the FDA is taking action to restrict the sale of unapproved ingestible fluoride prescription products for young children. We’ve sent notices to 4 companies outlining the agency’s intention to take action against those that market unapproved fluoride-containing ingestible drug products. https://www.fda.gov/news-events/press-announcements/fda-acts-protect-children-unapproved-fluoride-drug-products

FDA concluded that such products should not be used in children under age three or by older children who are not at high risk of tooth decay. For the same reason fluoride may work to kill bacteria on teeth, it may also alter the gut microbiome, which may have broader health implications. Better alternatives exist to protect children's teeth.

10/31/2025

Hosting a spooktacular party at home? Don't let frightful bacteria crash the fun! Keep perishable party foods like finger sandwiches, cheese platters, salads, cold pasta dishes with meat or seafood, and cream-filled desserts chilled until serving time to help avoid foodborne illness. Use these other simple food safety tips from the U.S. Food and Drug Administration to ensure certain treats are safe for your child. https://www.fda.gov/food/buy-store-serve-safe-food/halloween-food-safety-tips-parents

10/30/2025

2025 Innovation Award Honoree Critical Path Institute creates groundbreaking tools and partnerships that accelerate drug development, advance life-saving therapies, and redefine how regulatory science improves public health.

Learn more about our 2025 Honorees: https://reaganudall.org/news-and-events/awards/innovations-regulatory-science-policy-awards

10/24/2025

By making science-based education accessible in multiple languages and formats, 2025 Leadership Award Honoree the Produce Safety Alliance has transformed how the produce industry understands and applies regulatory science, strengthening the safety of our food supply.

Learn more about our 2025 Honorees: https://reaganudall.org/news-and-events/awards/innovations-regulatory-science-policy-awards

10/23/2025

How should our nation respond to outbreaks?

Our latest report, Addressing Cross-Sectoral Health Issues: A Collaborative Approach, outlines way to integrate human, animal, and environmental health efforts through improved coordination, communication, and shared research.

Developed in collaboration with the U.S. Food and Drug Administration and partners across sectors, the report highlights strategies to strengthen our collective readiness for future outbreaks.

Read the report: https://reaganudall.org/publications/addressing-cross-sectoral-health-issues-collaborative-approach