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Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights

The Premier Consulting Blog

Working to bring these valuable new therapies to patients, sponsors engaged in strategic development often approach Premier Consulting for regulatory clarification: β€œIs this actually a combination product? e) reveals more detail β€” and gray areas: Two or more regulated components, in one package (e.g., What do we need to do if it is?”