Development Strategies For Platform Devices Navigating Regulatory Complexities: Formulation, Compliance, And Market Approval

In the dynamic landscape of life sciences, platform technologies like prefilled syringes (PFS) and autoinjectors are reshaping the development of drug-device combination products. The on-demand webinar, Development Strategies for Platform Devices: Navigating Regulatory Complexities, addresses the opportunities and challenges of these innovations, particularly in navigating the FDA’s evolving regulatory landscape.

Attendees will gain insight into how platform technologies can accelerate time-to-market, reduce development costs, and mitigate risk—while still meeting stringent regulatory expectations. A key focus is on bridging formulation changes across delivery systems, such as transitioning from vials to PFS or autoinjectors. The webinar also explores how to leverage existing data to streamline regulatory submissions, helping teams avoid redundant testing and shorten approval timelines.

Importantly, the session provides actionable guidance on aligning development strategies with FDA expectations. By understanding the agency’s latest thinking on platform technologies, teams can optimize their regulatory approaches to improve submission success rates. The discussion emphasizes risk mitigation strategies, including how to demonstrate product safety and effectiveness, which are critical for gaining FDA approval.

Key learning objectives include understanding the FDA’s evolving approach to platform devices, optimizing regulatory strategies for bridging formulation changes, and de-risking development programs to accelerate market access. The webinar equips regulatory, development, and quality teams with the knowledge needed to navigate complexities and succeed in a competitive and highly regulated market.