FDA Safety Review of Mifepristone Will Continue Into 2027

The U.S. Food and Drug Administration has announced that its ongoing safety review of mifepristone, one of the most widely used medications for medical abortion in the United States, will continue into 2027.

Mifepristone was first approved in the U.S. in 2000 and is commonly used together with misoprostol. The FDA has repeatedly reaffirmed its safety and effectiveness over the years, while restrictions surrounding its distribution have changed.

The current review was ordered amid renewed political and legal challenges surrounding the medication. According to the FDA's latest update, the agency expects to complete its safety study by mid-December 2026 and publish its findings by March 2027.

The development is significant because regulatory decisions involving reproductive-health medicines can affect access to healthcare, prescribing practices and the way patients receive treatment.

The review itself does not represent a finding that mifepristone is unsafe. The FDA is continuing to evaluate the evidence before determining whether any regulatory changes are necessary.