Meeting | Virtual
Event Title
Public Meeting: FDA Rare Disease Day 2026
February 23, 2026
- Date:
- February 23, 2026
- Time:
- 9:00 a.m. - 4:00 p.m. ET
Meeting Recording
Watch the full meeting recording or for specific panels, please visit:
- Panel 1: FDA Initiatives to Advance Medical Product Development for Rare Diseases
- Panel 2: Getting All the Voices Together – How the Patient Community Can Engage with FDA
- Panel 3: Addressing Challenges and Opportunities with Artificial Intelligence (AI) Technology
- Panel 4: Using Real-World Data (RWD) and Real-World Evidence (RWE) at FDA to Promote Product Development for Rare Diseases
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
Contact
Please email any questions and/or comments to FDARareDiseaseDay@fda.hhs.gov.
Event Materials
| Title | File Type/Size |
|---|---|
| FDA Rare Disease Day 2026 – Agenda and Speaker Biographies | pdf (9.69 MB) |
| FDA Rare Disease Day 2026 –Slides | pdf (15.95 MB) |