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FDA Modifies Mifepristone REMS Program, Establishes Certification Process for Pharmacies | Polsinelli

On January 3, 2023, FDA released an updated Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. The updated REMS follows a December 2021 FDA announcement that it would. ....

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Danco Moves to Intervene in Lawsuit Challenging FDA Approval of Mifeprex®

/PRNewswire/ Today, Danco Laboratories (Danco) filed a motion to intervene in Alliance for Hippocratic Medicine v. FDA, a lawsuit in which several. ....

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FDA REMS Protocol Modification Provides a Pathway for Pharmacies to Dispense Mifepristone | Quarles & Brady LLP

On January 3, 2023, the U.S. Food and Drug Administration (FDA) modified its risk evaluation and mitigation strategy (REMS) program (“Mifepristone REMS Program”) to provide a process. ....

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FDA updates mifepristone REMS program

The Food and Drug Administration has updated its risk evaluation and mitigation strategy (REMS) on dispensing mifepristone that must be followed for mifepristone for medical termination of pregnancy through ten weeks gestation. Under the Mifepristone REMS Program, mifepristone must be dispensed by or under the supervision of a certified prescriber or by certified pharmacies for prescriptions issued by certified prescribers. Under the Mifepristone REMS Program, mifepristone may be dispensed in-person or by mail. ....

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