ABSTRACT
In Chapter 3, we provided the reader with a pathway to develop combination products successfully. One of the key domains in the pathway is the customer domain. While most of the efforts in this domain focus on the customer who is the end user of the product, there are efforts that focus on another “customer,” the regulatory agencies such as the Food and Drug Administration (FDA). Chapter 4 discusses meeting the expectations of the FDA and other regulatory agencies, and focuses on the regulatory requirements for combination products in both the EU and the United States. This chapter also provides an overview on the regulatory requirements in Canada, Japan, China, and India at the end of this chapter, as these are other key current or future markets for these products. The regulatory challenges for combination products, which may result in a fi nal product combination of devices, biologics, or drugs, are signifi cant and complex.
