Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights
The Premier Consulting Blog
NOVEMBER 8, 2022
Determining if you have a combination product The high-level definition of combination product seems straightforward: a product with at least two constituent parts, such as: Drug/biologic (e.g., metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e) therapeutic drug/monoclonal antibody) Drug/device (e.g.,
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