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

Reagan-Udall Foundation for the FDA

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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.

10/29/2026

The U.S. Food and Drug Administration is seeking stakeholder input on modernizing regulatory pathways for botanical drug products.

The Agency welcomes perspectives on current challenges, practical solutions, and approaches to strengthen the safety, efficacy, and consistency of plant-derived therapeutics.

Learn more and submit comments to the Federal Register by November 3: https://www.federalregister.gov/documents/2026/09/04/2026-18133/advancing-development-of-botanical-drug-products-request-for-information

10/28/2026

The public meeting on the U.S. Food and Drug Administration’s Rare Disease Framework has adjourned.

Thank you to the speakers and the many participants from the rare disease community who provided public comments on this important new initiative.

The meeting slides and speaker bios are available on our website, and the recording and transcript will be added next week. https://www.reaganudall.org/news-and-events/events/rare-disease-framework-public-meeting

10/28/2026

U.S. Food and Drug Administration Acting Commissioner Kyle Diamantas, JD, delivers remarks at the Rare Disease Framework Initiative public meeting.

10/28/2026

Kicking off today’s public meeting on the U.S. Food and Drug Administration’s new Rare Disease Framework Initiative, Foundation CEO Susan Winckler moderates a panel discussion with FDA’s Karim Mikhail, BPharm. MSc., Mike Davis, MD, PhD, and Amy Comstock Rick, JD.

10/27/2026

We're proud to announce the honorees of our 10th annual Innovations in Regulatory Science & Policy Awards.

Leadership Award: the late Peter Barton Hutt, former FDA Chief Counsel whose decades of service helped shape modern food and drug law

Innovation Award: City of Hope, for turning scientific discovery into new therapies and expanding access to clinical trials in cancer research and care

Advocacy/Policy Award: Angels for Change, for working to end drug shortages and keeping patients' experiences at the center of the solution

We'll celebrate them, and a decade of honoring work that advances regulatory science, on December 8. Learn more: https://www.reaganudall.org/news-and-events/awards/2026-innovations-regulatory-science-policy-awards

10/23/2026

The next event in the New Outsourcing Facility Discussion Series will focus on boosting quality and efficiency through automation.

Join us and the U.S. Food and Drug Administration to hear about the types of automation that can be incorporated into facilities — and the potential benefits and challenges.

To register, visit https://www.reaganudall.org/news-and-events/events/automation-basics-virtual-discussion

10/22/2026

Our upcoming meeting on global data harmonization will build on the recent report Modernizing Global Data Access and Exchange. Register for the meeting and view the report at https://reaganudall.org/news-and-events/events/global-harmonization-data-access-exchange

10/21/2026

Foundation CEO Susan Winckler shares a rapid recap from last week’s Patient Voice in Rare Disease Medical Product Development public meeting, held in collaboration with the U.S. Food and Drug Administration.

View the meeting slides and speaker bios on our website. Full recording and transcript coming soon!

https://www.reaganudall.org/news-and-events/events/patient-voice-rare-disease-medical-product-development

10/20/2026

Help the U.S. Food and Drug Administration reimagine its approach to rare disease drug development!

You have until 5pm ET today to request to provide public comment at the October 28 meeting on the Agency's new Rare Disease Framework Initiative.

Learn more, register to attend, and submit your request to comment: https://www.reaganudall.org/news-and-events/events/rare-disease-framework-public-meeting

10/19/2026

Members of the rare disease community are invited to provide input on the direction and focus of the U.S. Food and Drug Administration’s new Rare Disease Framework Initiative. If you’d like to comment at the October 28 public meeting, you have just one more day to request a slot. Register now: https://www.reaganudall.org/news-and-events/events/rare-disease-framework-public-meeting

Address

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

Website

http://reaganudall.org/

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