Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights
The Premier Consulting Blog
NOVEMBER 8, 2022
With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. 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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