The US Food and Drug Administration’s Regulation of Mifepristone

FDA oversight of mifepristone, developed during key moments from 2011 to 2023, has been shaped by scientific evidence and a cautious regulatory approach led by scientists at the agency.

Corresponding Author: G. Caleb Alexander, MD, MS, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, W6035, Baltimore, MD 21205 (galexan9@jhmi.edu).

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