FDA-NIH Rare Disease Day

Rare Disease Day® takes place worldwide, typically on or near the last day of February each year, to raise awareness among policymakers and the public about rare diseases and their impact on patients’ lives. This year, the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) and the U.S. Food and Drug Administration, both agencies within the Department of Health and Human Services (HHS), will sponsor a shared Rare Disease Day event as part of this global observance.

The 2025 FDA-NIH Rare Disease Day is a two-day meeting on Thursday, February 27 and Friday, February 28, 2025, from 10 a.m. to 4 p.m. EST each day. The meeting will take place online (virtually) and in-person in Bethesda, Maryland, on the NIH campus in the Natcher Conference Center. For more information about NIH campus security and how to get to NIH, please visit https://www.nih.gov/about-nih/visitor-information.

FDA-NIH Rare Disease Day aims to provide the rare disease community—patients, caregivers, families, patient advocate groups, researchers, clinicians, health care providers, and trainees/students —with information relevant to their lived experiences, including activities by FDA and NIH that promote research and product development for this underserved population.

The goals of FDA-NIH Rare Disease Day are to:

• Demonstrate the NIH and FDA commitment to advancing research and regulatory support for people with rare diseases.
• Highlight NIH and FDA supported rare diseases research and the development of diagnostics and treatments.
• Initiate a mutually beneficial dialogue among the rare diseases community.
• Exchange the latest rare diseases information with stakeholders to advance research and therapeutic efforts.
• Shine a spotlight on stories told by patients living with a rare disease, their caregivers, and their communities.

FDA-NIH Rare Disease Day seeks to bring together a broad audience including patients, patient advocates, caregivers, health care providers, researchers, trainees, students, industry representatives, and government staff.

Meeting registration information will be posted soon! The public will be able to attend in-person on the NIH campus in Bethesda, Maryland or online (virtually).