FDA to Finalize Abortion Pill Safety Review by March
FDA announces plan to complete mifepristone safety review by March, amid ongoing legal and political debates over access.
POLICY WIRE — City, Country — The U.S. Food and Drug Administration has announced it will finalize its safety evaluation of the abortion pill mifepristone by March, according to a recent court filing.
The agency plans to assess mifepristone’s safety compared to surgical abortions up to 10 weeks of pregnancy, analyzing side effects in around 100,000 women who used the drug. Results are expected by mid-December, with a final report anticipated by March.
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Mifepristone was approved in 2000 and has been widely studied, with research consistently showing it to be safe and effective. In 2021, the FDA temporarily allowed remote prescriptions, which were finalized in 2023. The agency now says it will reassess that policy based on new data, considering input from patients, providers, and additional studies not reviewed previously.
Reporting by Policy-Wire (PW)



