CTTI has released the Enabling Expedited Pathways booklet, the first deliverable from an ongoing project examining the use of U.S. Food and Drug Administration (FDA) and other international regulatory expedited programs for drugs, biologics, and devices. Designed to accelerate the development and review of medical products for serious conditions and areas of unmet medical need, these programs offer an opportunity to understand efficiency more broadly.

Developed through an informal review of publicly available information and project team discussions, the booklet provides an overview of current FDA expedited pathways, including their purposes, potential benefits, and common challenges. Rather than recommending how expedited programs should be used, the resource provides a foundation for considering how these pathways have been applied across different development contexts and what can be learned from those experiences.

Building on this initial work, CTTI is exploring the factors that influence the use of expedited programs within FDA and other regulatory jurisdictions, including decision-making among applicants, regulators, patients, sponsors, and clinical research organizations. The project aims to identify lessons learned, better understand current practices and challenges, and explore opportunities where additional support or resources may be valuable.

These insights will help inform future CTTI efforts and potential recommendations, resources, or project activities.