Do You Have A Combination Product, And Is It Drug-Led Or Device-Led?

By Ryan Key, PhD, Manager, RA CMC

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%. 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? What do we need to do if it is?” They realize that proceeding down the wrong development pathway risks precious time and money, so it’s crucial to identify what kind of combination products they have, from the start.

This blog post aims to bring clarity to this confusing subject for sponsors.