One Pivotal Trial, the New Default Option for FDA Approval — Ending the Two-Trial Dogma

New England Journal of Medicine 2026

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Authors: Vinay Prasad, Martin A. Makary

DOI: 10.1056/nejmsb2517623

Cited by: 36

References: 8

Fields of Study & Subjects

Health Systems Economic Evaluations Quality of Life Biomedical Ethics and Regulation Economic and Financial Impacts of Cancer

References 8