Reagan-Udall Foundation for the FDA

Reagan-Udall Foundation for the FDA We're the FDA's foundation: a nonprofit, created by Congress, helping to modernize regulatory science. We're on it. And you can join us.

What better way to say nonpartisan than for Congress to name us after Ronald Reagan and Mo Udall? Back in 2007 the call to action was to identify, fund, and support projects and programs that help equip FDA staff with the highest caliber science and technology. For example, you can share our newly launched expanded access Navigator website with patients and physicians researching the complexities

of compassionate use. Or if you're a company, list your expanded access policies on the Navigator's Directory or check out our IMEDS public-private partnerships. Other ways to help us help FDA include donations to our Fellowship program or joining us at the first-ever "Innovations in Regulatory Science" Gala. It's all on our site www.reaganudall.org.

How can we enhance infant formula safety while maintaining a reliable and affordable supply for families?In July, the Fo...
09/03/2026

How can we enhance infant formula safety while maintaining a reliable and affordable supply for families?

In July, the Foundation convened a discussion to examine insights from recent infant formula recall activity and the latest research on C. botulinum. Our new report shares lessons learned and presents 22 recommendations to advance research, improve testing methods, strengthen data sharing, validate preventive controls, and improve collaboration.

Read the full report: https://reaganudall.org/publications/applying-science-infant-formula-safety

Advancing rare disease treatment requires a delicate balance: expediting clinical development while maintaining credible...
09/01/2026

Advancing rare disease treatment requires a delicate balance: expediting clinical development while maintaining credible, high-quality regulatory standards.

To bridge this gap, the Foundation brought together experts from medical research, patient advocacy, regulatory agencies, and regulated industry. Their joint insights, including 10 specific challenges and 20 actionable recommendations, are now available in our report: “Recommendations for Expanding Regulatory Agility and Evidentiary Integrity in Developing Treatments for Rare Diseases.”

Discover how cross-stakeholder collaboration is shaping the future of rare disease research. Download the full report: https://reaganudall.org/publications/recommendations-expanding-regulatory-agility-and-evidentiary-integrity-developing

We’re excited to share a key new article from the Journal of Women’s Health! In November 2025, the Foundation and the Mi...
08/21/2026

We’re excited to share a key new article from the Journal of Women’s Health! In November 2025, the Foundation and the Milken Institute’s Women’s Health Network convened leading advocates, clinicians, researchers, regulatory scientists, and investors for an invitation-only roundtable. Our goal? To tackle the lingering pain points across the drug development life cycle for conditions affecting women exclusively, differently, or disproportionately.

Read the article to discover actionable solutions for advancing women-centered product development and addressing health needs across the lifespan: https://journals.sagepub.com/doi/10.1177/15409996261463009

Are you a newly registered outsourcing facility deciding which drugs to produce? Developing your portfolio can be challe...
08/20/2026

Are you a newly registered outsourcing facility deciding which drugs to produce? Developing your portfolio can be challenging, yet it is a fundamental part of getting off to a good start. Join our August 25 discussion on Developing a Product Portfolio to learn how to maintain and evolve a portfolio and how customer relationships and operational capacity factor into decision making.

Register today: https://reaganudall.org/news-and-events/events/developing-product-portfolio

Join us, in collaboration with the U.S. Food and Drug Administration, for a hybrid public meeting to hear public comment...
08/17/2026

Join us, in collaboration with the U.S. Food and Drug Administration, for a hybrid public meeting to hear public comments on perspectives regarding the use of opioid medications for the management of pain & addiction. The meeting will also feature a federal partner panel discussion.

Public Comment Topics:
1. Scientific evidence regarding conditions of use, safety concerns, or benefit-risk assessment of opioid medications
2. Input on FDA’s regulation of opioid medications
3. Additional actions that could be considered to address the public health effects of opioid medications

The deadline to request to present public comment is Thursday, August 27. Learn more and register: https://reaganudall.org/news-and-events/events/addressing-public-health-effects-opioid-medications

The Expanded Access: Insights & Resources webinar is tomorrow! You'll learn key steps in the Expanded Access process, ex...
08/17/2026

The Expanded Access: Insights & Resources webinar is tomorrow! You'll learn key steps in the Expanded Access process, explore tools to support initiating and managing requests, and hear real-world insights from patient advocacy, academia, health care, and industry representatives.

If you have questions about Expanded Access, you won't want to miss this webinar!

Register today: https://reaganudall.org/news-and-events/events/expanded-access-insights-resources

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1333 New Hampshire Avenue NW Suite 420
Washington D.C., DC
20036

Opening Hours

Monday 8:30am - 5pm
Tuesday 8:30am - 5pm
Wednesday 8:30am - 5pm
Thursday 8:30am - 5pm
Friday 8:30am - 5pm

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