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Journal of Pharmaceutical Innovation · 2026 · Vol. 21 · Issue 6 · Springer
US Food and Drug Administration (USFDA) offers four Expedited Programs (EPs): Accelerated Approval (AA), Fast Track designation (FT), Breakthrough Therapy designation (BT) and Priority Review (PR). As Gadekar recently presented, understanding the frequency of EP assignment and application types is useful to inform regulatory strategies. This letter builds upon the previous analysis by examining the association between EPs and...