Affecting the Aging Trajectory:
Regulatory Constructs for Gerotherapeutic Drug, Biologic & Device Development
Hybrid Public Meeting
Virtual or In Person at 1333 New Hampshire Ave., NW, Washington, DC
May 27, 2026 | 10am-4pm (eastern)
Aging is the primary driver of virtually every major chronic disease, yet it remains largely absent from formal regulatory recognition as a therapeutic target. As researchers and product developers explore opportunities to improve the amount of time a person remains in good health and free from long-term disease or disability, identifying the appropriate regulatory construct is essential to shape research and regulatory review, assuring that interventions improve the public’s health.
On May 27, 2026, the Reagan-Udall Foundation for the FDA, in collaboration with ARPA-H and the XPRIZE Foundation, will convene a hybrid public meeting on exploring regulatory constructs for gerotherapeutic drug, biologic and device development. Key topic areas include
- discussing strategic use of Intrinsic Capacity (as defined by the WHO ICD-11 framework) and function-centered endpoints
- building on established pediatric growth curve paradigm by exploring a standardized “Adult Health Curve” tracking intrinsic capacity
- identifying functional features of aging, from midlife onward, as a serious medical condition
- exploring the application of patient-relevant and regulatorily acceptable endpoints from other areas (such as pediatric neurodegenerative diseases) to improve health throughout the lifespan