On-Body Drug Delivery Systems: Innovations to Enhance Patient Outcomes and Regulatory Success

In the rapidly evolving landscape of drug delivery, on-body delivery systems (OBDS) continue to stand out as a sophisticated integration of medical devices and pharmaceuticals, or combination products. These devices allow patients to administer large volumes of medicine in the comfort of their homes. Preprogrammed OBDSs minimize user/patient intervention to support patient adherence and, by extension, support clinical outcomes.

OBDS must comply with both medical device and pharmaceutical regulatory standards, presenting an inherent complexity for developers. This webinar explores the crucial regulatory requirements involved in the development and approval of these combination products and aims to guide stakeholders through the regulatory landscape to facilitate successful approval.