Ep. 16 Promise and Pressure: Unpacking FDA's Expedited Drug Pathways
Description
In this episode, we unpack how the Food and Drug Administration speeds up drug development for serious and underserved medical conditions. We explore five key designations that accelerate this process: Orphan Drug, Fast Track, Accelerated Approval, Priority Review, and Breakthrough Therapy.
You will learn how these programs help bring treatments to patients more quickly and how they are driven by both scientific urgency and public policy goals. We also examine the tradeoffs that come with speed, including smaller clinical trials, more post approval safety changes, and significantly higher costs for many of these therapies.
Featured Article: Special FDA Designations for Drug Development: Orphan, Fast Track, Accelerated Approval, Priority Review, and Breakthrough Therapy (https://doi.org/10.1007/s10198-023-01639-x)
United States
