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What Will FDA Do In Battle Over Medication Abortion Access?

Executive Summary

Attorneys discuss host of questions the agency faces in the wake of the Dobbs decision, including whether to take enforcement action against mifepristone REMS violations, whether to change restrictions on its use, and how to deal with challenges to its drug approval authority.

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New Attack Against FDA’s Mifepristone Approval Targets Potential Water Contamination

Students for Life of America requests that FDA revoke approval of mifepristone and REMS changes, claiming the agency failed to determine the medication abortion drug would not pollute waterways. The group’s fourth citizen petition follows similar claim that the agency failed to comply with the Endangered Species Act.

Order For Withdrawal Of Mifepristone Would Be ‘Unprecedented,’ Seismic Event; Wyden Says FDA Must Ignore It

Senator Wyden says the case has been "a rigged game all along" as state attorneys general and medical groups file briefs in the suit against the FDA.

Medical Organizations Push For Mifeprex Miscarriage Indication, REMS Elimination

The American College of Obstetricians and Gynecologists and 48 other groups request the FDA ask Danco Laboratories to file a supplemental NDA for an expanded indication and eliminate requirements for provider and pharmacist certification. For now, Danco is focused on updating the REMS as modified in December.

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