Have you ever wondered what is required for the FDA to authorize a drug for aging? During the #ARDD2026 event, FDA officials provided their most straightforward responses to date regarding this process.
Chief Scientist Steven Kozlowski confirmed that the next regulatory science agenda for the agency will feature this subject, stating directly that "aging and longevity will be one of those topics."
Additionally, the representatives detailed two acceptable methods to demonstrate that a medication effectively slows aging. Developers can either show that a treatment offers benefits across several age-related conditions, or they can prove it leads to a slower decline in physical and mental capacity. They also indicated that the first approvable trials will likely be conducted with older, higher-risk people.
For an excellent summary of these developments, check out the nice write-up by Lifespan available here: http://lifespan.io/fda-leaders-name-longevity-a-priority-at-ardd/
Chief Scientist Steven Kozlowski confirmed that the next regulatory science agenda for the agency will feature this subject, stating directly that "aging and longevity will be one of those topics."
Additionally, the representatives detailed two acceptable methods to demonstrate that a medication effectively slows aging. Developers can either show that a treatment offers benefits across several age-related conditions, or they can prove it leads to a slower decline in physical and mental capacity. They also indicated that the first approvable trials will likely be conducted with older, higher-risk people.
For an excellent summary of these developments, check out the nice write-up by Lifespan available here: http://lifespan.io/fda-leaders-name-longevity-a-priority-at-ardd/