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) The drug product is packaged and shipped as a solid powder.
52 
Let's personalize your content