FDA expects mifepristone safety review report by March 2027

The FDA told a court it expects to complete a safety study of mifepristone by mid-December this year and issue a report on its findings no later than March 2027. The filing was an update ordered by a federal judge in a Louisiana lawsuit challenging the drug’s delivery by mail. After the report, the agency will decide whether to make changes to how the drug is used.

Reports described the timeline differently. STAT, MedPage Today and ABC News said the study is expected to finish by mid-December, with the findings reported by March 2027. NBC News said the FDA expects to complete its review in March, after results are expected in mid-December. NBC reported that the FDA plans to examine side effects among roughly 100,000 women and compare the drug’s safety with surgical abortions through 10 weeks’ gestation. The Hill reported that the agency will not impose new restrictions before March.