Abstract
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 Time to Approval (TTA). As a population, marketing applications (MAs) granted EP are not developed much faster than applications where no EP was granted. Median TTA for MA with or without EP was found to be the same, at 6.9 years. Therefore, it is reasonable to question the capability of EP to predictably reduce TTA.