Fast Track Designation

By Sreya Julakanti, PharmD Candidate, and Antony Kaprielian

Fast Track Designation (FTD) is one of the FDA’s most impactful regulatory tools for accelerating the development and review of drugs and biologics intended for the treatment of serious or life-threatening conditions. Designed to increase communication and collaboration between drug developers and the FDA, FTD offers several significant advantages, not only helping developers bring promising therapies to patients faster, but also including more frequent meetings, rolling review, and potential eligibility for priority review, saving valuable time on the path to market. However, securing this designation requires a deep understanding of FDA criteria, as well as the data necessary to support the application.

Whether you're developing a novel therapeutic or looking to improve upon existing treatments, FTD can streamline your approval process, provided your strategy is sound and your submission meets FDA expectations. Discover how Pace can provide regulatory strategy, technical authoring, and direct FDA engagement to support your success as you navigate the Fast Track Designation process.