The FDA plans to update its Focus Areas of Regulatory Science (FARS) framework to highlight aging and longevity medicine, according to comments from the agency’s chief scientist at the Aging Research & Drug Discovery Meeting held at Harvard. Steven Kozlowski, MD, told attendees that the refreshed FARS report—scheduled for release early in federal fiscal year 2027—will focus on how regulators can quantify biological and clinical aspects of aging across diseases. He also emphasized the need for a pre-competitive, qualified, shared endpoint that can be used across trial programs. Acting Chief of Staff Lowell M. Zeta, JD, described longevity and healthspan as an important FDA and HHS priority and characterized the moment as an inflection point for regulatory adaptation. While Kozlowski did not provide an exact release date or specific deliverables beyond the update, his remarks tied the effort to endpoint qualification and trial design feasibility. For biotech developers, this is an actionable signal: aging-focused sponsors may expect more structured regulatory expectations around endpoints, evidence standards, and clinical trial architectures designed for multi-disease chronic aging populations.
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