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Authors
Hwang, Catherine S. https://orcid.org/0009-0004-0185-3256
Lu, Zhigang
Russo, Massimiliano
Zakoul, Heidi
Toyserkani, Gita A.
Zhou, Esther H.
LaCivita, Cynthia
Dal Pan, Gerald J.
Kesselheim, Aaron S.
Sarpatwari, Ameet
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Funding
Funding for this research was provided by:
U.S. Food and Drug Administration (75F40120C0044)
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Article History
Received: 15 June 2025
Accepted: 4 November 2025
First Online: 28 January 2026
Declarations
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: Ameet Sarpatwari served as an expert witness on REMS-related litigation concerning mifepristone. Cynthia LaCivita and Gita A. Toyserkani were employed by the FDA at the time this research was conducted. Cynthia LaCivita is currently a consultant at GlaxoSmithKline and United BioSource, and Gita A. Toyserkani is currently a consultant with DelMetrik. Catherine S. Hwang, Zhigang Lu, Massimiliano Russo, Heidi Zakoul, Esther H. Zhou, Gerald J. Dal Pan, and Aaron S. Kesselheim have no conflicts of interest that are directly relevant to the content of this article. The views expressed in this article are those of the authors and do not necessarily represent those of the FDA or the US Government.
: The Mass General Brigham Institutional Review Board approved this survey study, and all participants provided informed consent. The institutional review board reference number is 2021P002109.
: All physician respondents consented to participate in our study.
: All physician respondents gave permission for us to publish our study results.
: Researchers whose proposed use of the data has been approved by the study team may get access to a data dictionary and deidentified participant data. Requests must be sent to the senior author at asarpatwari@hsph.harvard.edu.
: The code can be requested from the first author at hwangca@ohsu.edu.
