FDA's Rare Disease Day 2026 - Agenda Now Available

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  

This meeting is free and open to the public.