Combination products are medical products composed of 2 or more different types of individual medical products; for example, a drug plus dosing device (think of asthma inhalers or prefilled syringes) or a drug plus the solution needed to reconstitute it for dosing (think of a vaccine). Combination products are reviewed by a team led by a lead Center, generally the one responsible for the product component that provides the primary mode of action (PMOA) for the combination product. The team also includes reviewers from other Centers with responsibility over the other components of the product, and all reviewers work together to evaluate the combination product for safety and efficacy.

Because combination products, since their components are expected to interact, can be subject to specialized regulations, there is rarely a clearly defined pre submission pathway. To assist sponsors, the agency released a draft guidance in February 2019 that outlines the various pathways available and suggests options for agency interaction. The document outlines the pathways available for device-led, drug-led, and biologic-led combination products and includes some product examples in the Annex.

Text Copyright © 2019 Katrina Rogers