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FDA plans to complete its safety review of abortion medication by March

A court filing indicates regulators will review mifepristone data before deciding on possible regulatory changes.

Updated Oct 9, 2026 · 00:47 UTC5 reports

The short version

  • The FDA stated in a Justice Department court filing that its ongoing safety review of mifepristone is expected to finish by March, with a preliminary study wrapping up in mid-December.[CBS News · NBC News]
  • The agency plans to compare mifepristone outcomes to surgical abortions up to 10 weeks of gestation and evaluate side effect rates across roughly 100,000 women.[NBC News]
  • Regulators will assess the findings before deciding whether to revise drug rules or reconsider the 2023 policy permitting dispensing without an in-person visit.[CBS News · NBC News]
  • It remains uncertain what conclusions agency officials will draw from the findings or what specific restrictions could emerge.[CBS News · NBC News]

Key facts

  • The Justice Department filed court documents stating the FDA expects to finish its mifepristone safety review in March, with a study concluding by mid-December.[CBS News · NBC News]
  • The review compares mifepristone with surgical abortions up to 10 weeks of gestation, analyzing side effects among about 100,000 patients.[NBC News]
  • Health Secretary Robert F. Kennedy Jr. initiated the review following claims by a conservative think tank regarding higher complication rates, which reproductive health researchers described as unreviewed junk science.[NBC News]
  • The FDA is utilizing statistical data mining on health network and insurer incident databases to search for unknown safety concerns.[CBS News]
  • The agency plans to re-evaluate its 2023 determination removing in-person dispensing rules once the review is completed.[NBC News]

What remains uncertain

  • It is not yet known what regulatory conclusions the FDA will reach from the data or whether new restrictions will be implemented.[CBS News · NBC News]

Sources

Outlet counts describe coverage, not independent confirmation. Reports may share a wire service or original source.