Reagan-Udall Foundation for the FDA

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

10/16/2026

That concludes Patient Voice in Rare Disease Medical Product Development! We are grateful to everyone who participated in this compelling meeting. Visit our website to view the slides, and look for the recording and transcript to be added next week. https://reaganudall.org/news-and-events/events/patient-voice-rare-disease-medical-product-development

10/16/2026

A second panel discusses opportunities to advance patient voice in product development. With Allyson Berent, Foundation for Angelman Syndrome Therapeutics (FAST); Tom Croce, Jazz Pharmaceuticals; Jenn McNary, Canary Advisors; Donald Carlino, Novocure; Tamar Thompson, Alexion Pharmaceuticals, AstraZeneca Rare Disease; and Ashley Valentine, Sick Cells, joining U.S. Food and Drug Administration’s Michelle Campbell, Mona Elmacken, and Courtney Lias, moderated by Susan Winckler.

10/16/2026

Foundation CEO Susan Winckler moderates a U.S. Food and Drug Administration panel discussion on where the patient voice is sought across the development timeline, with Cynthia Grossman, Robyn Bent, and Carmen Matos.

10/16/2026

Amy Comstock Rick, Director of U.S. Food and Drug Administration's Rare Disease Innovation Hub, delivers the opening remarks at today’s hybrid public meeting, Patient Voice in Rare Disease Medical Product Development. https://reaganudall.org/news-and-events/events/patient-voice-rare-disease-medical-product-development

10/15/2026

As we look forward to tomorrow’s meeting on the patient voice in rare disease medical product development, we’re pleased to share another opportunity for members of the rare disease community.

Join us on October 28, in partnership with the U.S. Food and Drug Administration, for a hybrid public meeting seeking input on the Agency’s newly announced Rare Disease Framework Initiative. The initiative aims to develop a fit-for-purpose Framework that reflects the realities of rare disease drug development by considering the nuances of each disease, patient needs, product type, and the evidence that realistically can be generated in small patient populations.

Learn more and register: https://www.reaganudall.org/news-and-events/events/rare-disease-framework-public-meeting

10/14/2026

There's still time to register for our hybrid meeting on rare disease patient engagement, happening this Friday with the U.S. Food and Drug Administration. To register and view the agenda, visit https://reaganudall.org/news-and-events/events/patient-voice-rare-disease-medical-product-development

10/13/2026

Our webinar on featured insights from patient advocacy, academic, healthcare, industry, and regulatory experts. Watch the panel discussion:

This informational webinar offered a “101-level” overview of how th...

10/09/2026

Automation can help outsourcing facilities increase quality and efficiency, but what should facilities consider when incorporating automation? Join us and the U.S. Food and Drug Administration for this virtual discussion, part of the New Outsourcing Facility Discussion Series. Register now: https://reaganudall.org/news-and-events/events/automation-basics-virtual-discussion