Challenges and Regulatory Solutions in Post-Marketing Safety Surveillance of Diabetes-Focused Drug-Device Delivery Systems

Introduction: Diabetes mellitus, a prevalent chronic metabolic disease, requires effective management strategies to mitigate its impact on individuals worldwide. Innovative drug delivery systems have emerged as potential solutions to enhance diabetes treatment outcomes. However, ensuring the safety and efficacy of these systems necessitates robust post-marketing safety surveillance and compliance with regulatory guidelines. Aim: This paper provides a comprehensive analysis by synthesizing information from multiple sources, focusing on the challenges and regulatory solutions in the European Union (EU) and the United States (US) specific to post-marketing safety surveillance of diabetesfocused drug delivery systems. Additionally, it briefly discusses the specific case of ICTA 650, a type 2 diabetes drug-device combination product, within the broader context of post-market safety surveillance. Method: The structure of this abstract follows a systematic review approach, which involves an examination of current literature such as PubMed, Google Scholar, Embase and regulatory guidelines pertaining to problems with post-market surveillance requirements for drug-device combinations in the treatment of diabetes. Results: By addressing challenges in adverse event reporting and fostering effective collaboration, we can establish a safer environment for all diabetes drug-device combinations, ensuring that each piece fits seamlessly into the broader landscape of post-market safety surveillance. In the context of post-market safety surveillance, ITCA 650 provides an interesting case. While its primary issues are related to premarket approval, the repeated rejections by the FDA offer valuable insights into the significance of rigorous safety assessments. Despite its aspirations to join the realm of diabetes drug-device combination products, ITCA 650 has encountered substantial obstacles due to concerns regarding its safety profile. The FDA's rejections emphasized risks such as acute kidney injury (AKI) and major adverse cardiovascular events (MACE), underscoring the importance of robust surveillance systems1. Although the inclusion of ITCA 650 in a discussion focused on post-market safety might seem tangential, it serves as a reminder that comprehensive evaluation and ongoing monitoring of potential risks are essential. Drug-device combinations, such as transdermal systems, hold promise in enhancing treatment outcomes and require regulatory scrutiny to ensure their safet