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Mifepristone REMS Program

Federal Court of Appeals Panel Issues Ruling in Litigation Challenging FDA Approval of Mifepristone

[08/31/23]

Posted on August 31, 2023 in Health Law News, Litigation Analysis

Published by: Hall Render

On August 16, 2023, a three-judge panel of the Fifth Circuit Court of Appeals issued an opinion in the ongoing litigation regarding the U.S. Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name Mifeprex), a drug used in medically induced abortions. The panel vacated in part and affirmed in part a... READ MORE

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FDA Expands Access to Mifepristone: Next Steps for Providers and Retail Pharmacies

[02/07/23]

Posted on February 7, 2023 in Health Law News

Published by: Hall Render

On January 3, 2023, the U.S. Food and Drug Administration (“FDA”) released an updated Mifepristone Risk Evaluation and Mitigation Strategy (the “Mifepristone REMS Program”), which reverses the requirement that the drug be dispensed directly to a patient by certified prescriber in a clinic or a medical office (the “in-person dispensing requirement”). The updated Mifepristone... READ MORE

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