Injectable Combination Product Development: Facilitating Risk-Based Assessments for Efficiency and Patient Centric Outcomes.

Abstract Combination products (CPs), designated by the US Food and Drug Administration (FDA), continue to be on the rise, from the innovation of novel medicines and greater demand for injectable home and self-administration. CP qualification, its constituent parts or intended use, will depend upon the regulatory jurisdiction with reference to the product’s primary mode of action. In the case of a drug product combined with a device, a consult or collaborative review process involving different Centers within the FDA may be necessary. Policies and practices from different legislative branches of government will need to be merged for a single application. This presents a challenge for aligning information for the application dossier as it relates to a drug master file or drug-device CP design history file. A common objective for both pharmaceuticals and devices is to identify and evaluate patient risks to be mitigated, controlled, and managed across the drug product lifecycle. These concepts are reflected in the regulatory practices of pharmaceutical quality by design and device design controls. Early stakeholder engagement with this dynamic process between different regulatory paradigms becomes an advantage. This manuscript describes aspects for early planning for injectable drug-device development to facilitate time to market with patient centric solutions.