Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights
The Premier Consulting Blog
NOVEMBER 8, 2022
Working to bring these valuable new therapies to patients, sponsors engaged in strategic development often approach Premier Consulting for regulatory clarification: “Is this actually a combination product? metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e) What do we need to do if it is?”
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