FDA requirements for combination therapies

By Dr Nicola Davies

Combination therapies comprise two or more different types of medical products, including drugs, devices, and biological products.1 These individual components of combination therapies are called constituent parts, which might be physically or chemically combined and produced as a single entity (single entity combination product), packaged together as one unit (co-packaged combination product), or distributed separately (cross-labeled combination product).2

The US Food and Drug Administration’s (FDA) Office of Combination Products is responsible for the regulation of these products.1 We discuss some of the FDA’s requirements with respect to product characteristics, regulatory processes, current good manufacturing practices (cGMP), and post-marketing activities.