FDA Expedited Programs – What You Need To Know

Bringing therapies for serious conditions to patients faster can be a critical competitive and development advantage. FDA’s expedited programs—including Fast Track, Breakthrough Therapy, Priority Review, Accelerated Approval, Regenerative Medicine Advanced Therapy (RMAT), and Qualified Infectious Disease Product (QIDP) designations—offer sponsors opportunities to accelerate development, strengthen regulatory engagement, and potentially shorten time to market.

Understanding the eligibility criteria, benefits, and timing considerations for each pathway is essential for building an effective regulatory strategy. This infographic provides a practical overview of FDA’s key expedited programs, highlighting how they can support products that address serious diseases and unmet medical needs. It also outlines when sponsors should engage FDA, what evidence is required, and how these pathways can be leveraged throughout development to optimize resources, reduce risk, and advance promising therapies more efficiently.