One Pivotal Trial, the New Default Option for FDA Approval — Ending the Two-Trial Dogma
V
Vinay Prasad
M
Martin A. Makary
(Food and Drug Administration, Silver Spring, MD)
Article Details
Journal
New England Journal of Medicine
Volume / Issue
Vol. 394, Issue 8
Published
February 19, 2026
Pages
815-817
ISSN
0028-4793
Publisher
Massachusetts Medical Society
Journal Info
New England Journal of Medicine
Massachusetts Medical Society
ISSN: 0028-4793 Social Sciences
Authors (2)
V
Vinay Prasad
M
Martin A. Makary
Food and Drug Administration, Silver Spring, MD
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