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.

Mifepristone
Groups advocate for expansion of the mifepristone indication and elimination of its REMS. • Source: Shutterstock

As the Biden administration has fallen short on pledges to increase access to medication abortion, medical organizations are advocating for the US Food and Drug Administration to eliminate restrictions on use of Mifeprex (mifepristone) and expand its indication.

The American College of Obstetricians and Gynecologists submitted a citizen petition to the FDA on behalf of itself and...

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