Top FDA officials published a New England Journal of Medicine perspective declaring that a single well‑controlled trial will be the regulator’s new default for drug approvals, replacing the historical expectation of two independent pivotal studies. Commissioners Martin Makary and Vinay Prasad said the agency will emphasize complementary confirmatory evidence — mechanistic data, related‑indication studies, animal models or real‑world evidence — and retain discretion to require extra trials when warranted. The framing seeks to lower late‑stage development costs and accelerate approvals but has already sparked debate among developers and analysts over evidentiary standards and potential effects on approval certainty.