Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights
The Premier Consulting Blog
NOVEMBER 8, 2022
e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., typical drug device, biologic device) Two or more separate components, co-packaged (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.,
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