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, continue to be on the rise, from the innovation of novel medicines and greater demand for injectable home and selfadministration. 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 US Food and Drug Administration 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.

Considerations for the development of a field-based medical device for the administration of adjunctive therapies for snakebite envenoming

“…Identifying and evaluating human use-case scenarios and patient risks that can be mitigated, controlled, and managed throughout a product's lifecycle is critical for the development of combination products that combine both therapy and a device to administer that therapy( DeGrazio and Paskiet, 2020 ). Thus, we have identified potential use-related issues at the onset of the design process to enhance the safety and improve the usability of the product.…”

Quality by Design in Pharmaceuticals: A Review of its Impact on Regulatory Compliance and Product Quality

“…They emphasize the shared goal of pharmaceuticals and devices in identifying and evaluating patient risks throughout the drug product lifecycle. Regulatory practices that focus on pharmaceutical safety through design and device design controls reflect these principles [30].…”

“…focus on pharmaceutical safety through design and device design controls reflect these principles [30].…”

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