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    • HEALTH CARE REIMBURSEMENT NEWS—Federal rule targets IDR process inefficiencies with new disclosure and communication mandates
    • ADMINISTRATION OF FDC ACT—FDA GUIDANCE NOTICES: Statistical approaches to establishing bioequivalence guidance issued
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    • STRATEGIC PERSPECTIVES—Mail access to mifepristone continues for now but faces more potential obstacles
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    Health Law Daily Wrap Up, STRATEGIC PERSPECTIVES—Mail access to mifepristone continues for now but faces more potential obstacles, (Jun 1, 2026)

    Organizations Mentioned:Danco Laboratories, L.L.C. | GenBioPro, Inc.

    By Sheila Lynch-Afryl, J.D., M.A.

    In addition to the pending cases, the FDA is undertaking a “science-based safety review” of the mifepristone REMS.

    After the Fifth Circuit blocked the dispensing of mifepristone by mail in May—prohibiting telehealth access even in ...

    By Sheila Lynch-Afryl, J.D., M.A.

    In addition to the pending cases, the FDA is undertaking a “science-based safety review” of the mifepristone REMS.

    After the Fifth Circuit blocked the dispensing of mifepristone by mail in May—prohibiting telehealth access even in states where abortion is legal—the U.S. Supreme Court stayed the order pending appeal. While mifepristone access remains unchanged for now, impending challenges to abortion pill access remain. On addressing the merits, for example, the Fifth Circuit could reach a similar conclusion, or the Northern District of Texas could restrict access in a different case challenging the FDA’s approval of the abortion pill. The FDA is also undertaking a “science-based safety review” of the mifepristone Risk Evaluation and Mitigation Strategy (REMS). No matter the source, it is likely that mifepristone access will again be restricted and that the issue will reach the Supreme Court.

    To read the entire article, click here.

    Companies: Danco Laboratories, L.L.C.; GenBioPro, Inc.

    MainStory: StrategicPerspectives DrugNews HouseNews SenateNews DrugBiologicNews FDCActNews GenericDrugNews LabelingNews PrescriptionDrugNews ReproductiveHealthCareNews SafetyNews SupremeCtNews

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