FDA Signals Aging and Longevity Will Be Included in Next FARS Update; Officials Discuss Regulatory Paths

# What happened At the Aging Research & Drug Discovery Meeting (ARDD 2026) in Boston, senior FDA officials said aging and longevity will be highlighted in the agency's next Focus Areas of Regulatory Science (FARS) report. FDA Chief Scientist Steven Kozlowski said the updated FARS is expected early in fiscal year 2027 and emphasized the agency's interest in developing usable regulatory tools for this field.

# Why the agency is focused on aging now FDA leadership framed aging as a common risk factor across many chronic diseases. The agency is looking for ways to connect biological measures of aging to clinical outcomes so developers can design trials that regulators can assess consistently. Lowell M. Zeta, acting chief of staff in the FDA's Office of the Commissioner, described longevity and healthspan as an important topic for both the agency and HHS and called the moment an inflection point for how FDA adapts to evolving science.

# What officials want: a shared endpoint Kozlowski said the agency would like a shared, pre-competitive endpoint that is qualified and broadly usable. He listed concrete attributes for such an endpoint:

• Regulatory acceptance so sponsors and reviewers buy into it.
• Feasible clinical trial designs that make studies practical to run.
• Use as a standard for later innovations to improve accessibility for researchers.

A qualified, shared endpoint aims to reduce fragmentation in how aging interventions are evaluated and to make results more comparable across studies.

# Two regulatory paths for gerotherapeutics Jeffrey Siegel, director of the FDA's Office of Drug Evaluation Sciences, outlined two pragmatic ways regulators could consider aging when evaluating therapies:

1) Demonstrate a common mechanism affecting multiple aging-related diseases. If the same mechanism reduces incidence or progression across two or three distinct aging-associated conditions, that pattern could support generalization to aging biology.

2) Measure effects on general, person-centered aging domains. Trials could target populations at risk of aging-related decline and show that treatment slows deterioration in domains such as frailty, cognition, hearing, or vision. Evidence that treated patients fare better than controls on these domains could support claims about functional benefit tied to aging.

# Related programs and investments Andrew Brack of ARPA-H moderated the panel and oversees PROSPR (PROactive Solutions for Prolonging Resilience), a $144 million initiative to redefine how aging and functional decline are measured and treated. That investment runs in parallel with FDA's regulatory science work and reflects a broader, coordinated push to develop biomarkers and endpoints that can support clinical development.

# What this means for researchers and developers Expect more regulatory guidance and focus on validated outcome measures in the coming year. Developers should monitor the FARS update and consider how candidate therapies might be evaluated under the two paths described: evidence across multiple diseases or targeted demonstrations of benefit in aging-related functional domains. Early engagement with regulators around endpoint qualification and trial feasibility will likely help align study designs with the agency's expectations.

# Next steps and timing Kozlowski said the updated FARS would be released early in FY 2027 but gave no specific date. Stakeholders should watch for that report as it will indicate which research and measurement gaps the FDA sees as priorities and may outline next steps for endpoint development and qualification.