Overview

A small pharmaceutical client developing a 505(b)(2) New Drug Application (NDA) for a Parkinson’s indication sought G&L Healthcare Advisors’ expertise to navigate the regulatory complexities of a drug-device combination. 

The product involved a software-controlled infusion pump to deliver an approved therapeutic, with requirements for both the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) compliance. 

G&L was engaged to provide strategic guidance for a successful Investigational New Drug (IND) application submission.

Challenges

The client faced several unique regulatory challenges with this combination product:
Drug-device integration: Combining an approved therapeutic with a software-controlled infusion pump introduced U.S. Food and Drug Administration (FDA) device-specific requirements that needed careful navigation.
CDRH compliance: The FDA's CDRH mandated extensive studies on biocompatibility, human factors, and risk management, areas where the client required expert guidance.
Non-clinical studies for dual compliance: Meeting both CDER and CDRH standards required specialized non-clinical study design and interpretation.
Regulatory strategy for software updates: The software control mechanism required a strategic approach to streamline future updates without necessitating extensive NDA supplements.

G&L’s Approach and Solution

G&L developed a targeted regulatory strategy that addressed both drug and device requirements efficiently, enabling the IND submission to proceed without the need for an Investigational Device Exemption (IDE). Key activities included:
Device-specific strategic guidance: G&L guided the structuring of the IND to incorporate the device components, eliminating the need for a separate IDE submission.
Software and device submissions strategy: G&L advised on submission strategies for future software changes and device design controls, allowing for software updates without triggering NDA supplements.
Non-clinical study guidance: G&L supported the client in designing and interpreting critical non-clinical studies to meet CDRH’s expectations for biocompatibility, human factors, and risk management.
Risk management and human factors integration: G&L collaborated with the client to develop a comprehensive risk management plan and provided oversight on human factors studies, ensuring compliance in the Module 3 (M3) section of the IND.

Impacts and Outcomes

G&L's support provided the client with a streamlined regulatory path that minimized delays and ensured regulatory compliance. Key outcomes included:
Avoided IDE requirement: G&L’s strategic approach enabled the client to proceed with the clinical study under the IND, without requiring a parallel IDE submission.
Comprehensive IND submission: The client successfully submitted a fully compliant IND, addressing all drug and device elements in alignment with both FDA CDER and CDRH regulatory requirements.