The FDA is set to broaden its regulatory science focus to aging and longevity, signaling that the agency plans to treat “healthspan” endpoints as a cross-cutting theme for future guidance. FDA Chief Scientist Steven Kozlowski, MD, said the updated Focus Areas of Regulatory Science (FARS) report will add aging and longevity topics and that the agency is seeking shared, pre-competitive endpoints usable in feasible clinical trial designs. In a separate move, the FDA opened a clinical trial modernization office within CDER, aimed at speeding up clinical trials. The development reflects the agency’s push to streamline how trials are designed, conducted, and coordinated—an effort that could affect timelines across drug and biologics programs. Together, the updates point to a near-term regulatory priority on trial feasibility and endpoint standardization in emerging areas such as aging medicine—areas where evidence generation has historically been fragmented.
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