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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

e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., While this meeting is optional, it often yields time-saving information. therapeutic drug/monoclonal antibody) Drug/device (e.g., insulin injector pen) Multiple drugs/device (e.g.,