Top FDA officials wrote in the New England Journal of Medicine that the agency will adopt a single‑pivotal‑trial default for drug approvals, signalling an explicit policy shift from the long‑standing two‑trial expectation. Commissioner Marty Makary and CBER Director Vinay Prasad argued the two‑trial dogma is outmoded and that one well‑controlled trial plus confirmatory biological or real‑world evidence can suffice. The perspective explains the agency’s new “default” while preserving discretion to require additional studies for unclear mechanisms or risky endpoints. Industry and investors are weighing the implications: sponsors could face lower late‑stage costs and faster timelines, but reviewers and some outside scientists warn about increased reliance on surrogate and mechanistic data.