Overview
- The FDA told a federal court on Thursday that it expects to obtain study results by mid-December and to finish interpreting the data and issue a final report by March 2027.
- The review will compare roughly 100,000 women who used mifepristone with about 100,000 women who had surgical abortions and will use the agency’s Sentinel databases plus a TreeScan analysis to look for unexpected safety signals.
- The agency said it will decide whether to revise mifepristone’s Risk Evaluation and Mitigation Strategy, including the 2023 decision that allowed telehealth prescribing and mail delivery, only after the review is complete.
- Anti-abortion groups and some Republican officials immediately criticized the timeline as too slow, while courts in ongoing suits such as Louisiana v. FDA have paused litigation or stayed enforcement while the agency conducts its study.
- Mifepristone has been FDA‑approved since 2000 and prior agency and academic work has found serious adverse events to be rare, but the review responds to contested claims and could materially affect access, state conflicts, and patients who rely on telehealth and mail delivery.