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Authors
Chimonas, Susan https://orcid.org/0000-0002-7742-5950
Cosenza, Carol
Kesselheim, Aaron S.
Toyserkani, Gita A.
Oswell, Kate Heinrich
LaCivita, Cynthia
Dal Pan, Gerald J.
Sarpatwari, Ameet
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Funding
Funding for this research was provided by:
Center for Drug Evaluation and Research (75F40120C0044)
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Article History
Received: 5 July 2025
Accepted: 4 November 2025
First Online: 27 November 2025
Declarations
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: SC, CC, GAT, KHO, and GJD have nothing to disclose. AS reports serving as an expert witness in litigation challenging the implementation of the mifepristone REMS program. ASK reports serving as a co-investigator on an unrelated FDA-funded project related to generic drug-device combinations.
: The study was approved by the Mass General Brigham IRB and the UMass Boston IRB.
: As approved by the Mass General Brigham IRB and the UMass Boston IRB, such consent is implied by participation
: As approved by the Mass General Brigham IRB and the UMass Boston IRB, such consent is implied by participation
: Data for this study are in a repository and are available upon request.
: N/A.
: All authors contributed to the conception and design of the study, the acquisition, analysis, and interpretation of data, and the drafting/revising of the manuscript. All authors read and approved the final version.
