FDA Breakthrough Therapy Designation Reduced Late-Stage Drug Development Time

Health Affairs July 1, 2024
Kathleen L. Miller, Ariel D. Stern, Aaron Kearsley, Jennifer Kao

Abstract

The Food and Drug Administration’s (FDA’s) breakthrough therapy designation (BTD) program was created to increase patient access to safe and effective therapies by supporting the efficient clinical development of qualifying, clinically meaningful therapies. Using a new data set of key development milestones for drugs approved between 2006 and 2020, including both BTD drugs and a set of comparator drugs identified by FDA experts, we estimated the BTD program’s...

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