In this FOIA request, we sought information regarding mifepristone safety data, including FAERS data and case reports created by FDA scientists reviewing FAERS data. This data and information will help show the safety and adverse event information that should be the basis of any future action by FDA regarding mifepristone. The case reports are especially important because FAERS data is raw data, and the case reports often detail determination by FDA scientists about the causation of the adverse events, severity, and the need for regulatory action.

Submitted: 5/1/2025
30-day response due: 7/11/2026

Status: In Agency Negotiations