The FDA updated its mifepristone guidance, detailing ongoing work on a safety study and the current status of the drug’s Risk Evaluation and Mitigation Strategy program.
According to an April 8 news release, the agency said it is still collecting and evaluating data needed for a “well-controlled study with adequate statistical power.” Next steps include data exploration, validation and peer review before conclusions are finalized.
Once the analysis is complete, the FDA will determine whether changes to the REMS program are warranted.
The update comes as legal challenges to mifepristone access continue. On April 8, a federal judge declined to block the mailing of the drug nationwide and directed the FDA to provide an update on its review within six months.
The FDA also reiterated in the news release that a January 2023 modification removed the in-person dispensing requirement and allowed certified pharmacies to dispense mifepristone.
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