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Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights

The Premier Consulting Blog

NOVEMBER 8, 2022

prefilled syringe) A drug used with a specified device in clinical trials — but that may be used with other devices once marketed (e.g., prefilled syringe) A drug used with a specified device in clinical trials — but that may be used with other devices once marketed (e.g., therapeutic drug/monoclonal antibody) Drug/device (e.g.,

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