Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights
The Premier Consulting Blog
NOVEMBER 8, 2022
e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., By allowing the agency to review the development plan in advance, you can learn whether regulators view it as sufficient, identify missing components, and understand the FDA’s thinking regarding your product.
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