Public Meeting: FDA Rare Disease Day 2026

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Date: February 23, 2026 Time: 9:00 a.m. – 4:00 p.m. ET

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Summary

FDA will host Rare Disease Day, a virtual public meeting, on Monday, February 23, 2026 in global observance of Rare Disease Week. The theme is: “Moving Forward. Looking Ahead. An Event for Patients.” The goal of this year’s Rare Disease Day is to explore ways to engage and collaborate with patients and their communities to support and accelerate the development of medical products for rare diseases. We want patients to connect with FDA and stay involved with our outreach and engagement programs to ensure the patient voice informs medical product development and regulation throughout FDA.  Panels will discuss:  

• Patient Focused FDA Initiatives 
• Patient Engagement Opportunities 
• Addressing Challenges and Opportunities with AI Technology
• Utilizing Real World Data and Real World Evidence at FDA

Please find the registration form below. Please note that registrants will not receive a confirmation email upon submission of this form. The Rare Disease Day team will send all registrants a streaming link closer to the event. If you have any questions, please email FDARareDiseaseDay@fda.hhs.gov. We look forward to your participation!

Agenda and materials

When available, agenda and slides can be found below, under Event Materials.

Contact

Participants may submit questions in advance to FDARareDiseaseDay@fda.hhs.gov.  

Event Materials

Agenda, slides, and other event materials will be added once available. 

• Content current as of:

  12/04/2025

• Regulated Product(s)

  Health Topic(s)

Source