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

Area of Science:

• Regulatory Science
• Pharmaceutical Development
• Medical Device Engineering

Background:

• Combination products (CPs) are increasing due to novel drug innovation and demand for home self-administration.
• Regulatory approval for CPs depends on the primary mode of action and jurisdiction.
• Drug-device CPs often require collaborative reviews between different US Food and Drug Administration (FDA) Centers.

Purpose of the Study:

• To outline strategies for early planning in injectable drug-device development.
• To address challenges in aligning regulatory information for combined drug and device applications.
• To facilitate timely market entry for patient-centric combination product solutions.

Main Methods:

• Review of regulatory requirements for combination products.
• Analysis of challenges in integrating drug master files and design history files.
• Emphasis on early stakeholder engagement and cross-disciplinary collaboration.

Main Results:

• Aligning policies from different government branches is necessary for a single application.
• Integrating information for drug master files and design history files presents a challenge.
• Patient risk management is a common objective for both drug and device components.

Conclusions:

• Early planning and stakeholder engagement are advantageous for navigating complex regulatory landscapes.
• Adopting principles of quality by design and design controls aids in risk mitigation.
• Streamlined development processes can accelerate the delivery of innovative injectable combination products to patients.