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Recent Rulings on Mifepristone Access: Implications for FDA and Stakeholders

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Recorded May 4, 2023 | On-Demand Webinar

On April 7, two federal courts issued conflicting rulings concerning FDA approval of mifepristone. The holding in Alliance for Hippocratic Medicine v. FDA resulted in a preliminary injunction that imposes a nationwide “stay” of FDA’s approval of this drug. Washington v. FDA, however, resulted in a preliminary injunction enjoining FDA from suspending access to the drug in 17 states and the District of Columbia. DOJ has already appealed to the Supreme Court to restore full access to this drug. How will these judicial decisions affect the medical community and patients? What are FDA’s options in responding to these two conflicting cases? What are the broader implications for FDA and drug manufacturers around product approvals?

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