ABSTRACT
The regulatory strategy for the combination product is critical for guiding activities from development through lifecycle management of combination products. This chapter focuses primarily on the development and refinement of the regulatory strategy and submission planning and execution for drug Primary Mode of Action (PMOA) combination products, which combine a drug or biological product with a medical device. Many of the concepts discussed can also be applied for device PMOA combination products and for drug-biologic combination products. This chapter outlines the key considerations for developing the strategy, including (i) product designation and jurisdiction, (ii) implications of the commercial presentation and identification of the regulatory design inputs, and (iii) combination product regulatory strategy execution.
