Combined Label Claims for Drug + DTx Combinations

As more DTx-drug combinations emerge, regulation is becoming increasingly important. New models are emerging, and there is uncertainty and confusion around what label claims DTx and Pharma companies should make for their combined therapies. The approach remains open to interpretation depending on the type of combination, therapeutic area, and geography. In this meeting we want to focus on a key question: what label claims can companies make about their DTx-drug combinations? More specifically, we will discuss the following questions: