New device QMSR includes significant changes for combination products

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The new Quality Management System Regulation (QMSR) that became effective on February 2, 2026, includes significant changes in the regulatory framework for combination drug-device and biologic-device products, especially those overseen through approved applications by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER)….
By: Hogan Lovells
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