 
Patient Voice in Rare Disease Medical Product Development
On October 16, 2026, the U.S. Food and Drug Administration, in partnership with the Reagan-Udall Foundation for the FDA (Foundation), will convene a hybrid meeting to explore the patient voice in rare disease medical product development (biologic, drug, and device).
The meeting will explore where the patient voice is sought across the development timeline, its impact, and additional opportunities for patients to engage in the product development process. Insights from these discussions will help inform recommendations for product developers and regulators to consider as they advance patient-centered approaches in their work.
The Public Engagement Staff resides within the Office of External Affairs. We aim to build stronger relationships with health professional organizations, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations. For more information, please contact us at PublicEngagement@fda.hhs.gov. For patient specific inquiries, please contact us at Patients Ask FDA.
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