Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights
The Premier Consulting Blog
NOVEMBER 8, 2022
The FDA response to these inquiries provides essential guidance on how you will proceed : Differences in regulatory process between drug-led and device-led combination products Drug-led Device-led Review focus Review Focus: efficacy, potency, safety — typical drug studies Review Focus: device action, compliance with ISO and other applicable standards (..)
52 
Let's personalize your content