At ARDD 2026, senior FDA officials said the agency will publish a focus-areas-of-regulatory-science document that names aging and longevity. They sketched the likely path: start with hard endpoints, prevention of age-related disease or death, in enriched high-risk groups, then validate measures for wider use. Chief Scientist Steven Kozlowski floated a shared "G factor" for aging. Andrew Brack of ARPA-H moderated. ARPA-H's PROSPR program (up to $144M over five years, announced in February) is funding the trials and endpoints, built around intrinsic capacity, that this path will need.
Why it matters
The regulator is no longer asking whether aging is a target. It is asking how to measure it. The first approvals will come through comorbidity prevention, so the patients you enroll and the outcomes you track today are the evidence base.
Originally published in The Longevity Medicine Intelligence newsletter.
