FDA Commissioner Marty Makary and CBER Director Vinay Prasad published a New England Journal of Medicine perspective formalizing a new regulatory default: one well‑controlled pivotal trial can suffice for drug approval. They said sponsors should supply “confirmative evidence” — mechanistic data, real‑world evidence, or data from related indications — to bolster single‑trial submissions. The authors emphasized the agency will retain discretion to require additional trials when mechanisms are unclear or endpoints are surrogate and short‑term. Industry analysts note the policy aims to lower late‑stage costs and speed market access but could shift evidentiary burdens onto alternative data types and post‑market studies. Policymakers and some reviewers have already signaled debates over statistical robustness and regulatory precedent.