Project Title: Evaluating the Effectiveness of Expedited FDA Drug Approval Pathways

Abstract

Specific Aims: To determine how the FDA’s expedited pathways affect the regulatory review time of new molecular entities. Methods: A descriptive study using the Drugs@FDA database was performed to analyze drug approvals that occurred anytime between 2016 to 2023. Drugs that underwent NDA/BLA submission, but were not granted approval during this timeframe were excluded from the study. There have been 369 novel drug approvals from 2016 to 2023. The time between the NDA/BLA submission and the final approval of each novel drug was collected during this period. Results: New molecular entities that did not utilize any expedited pathway (n = 11) had an average regulatory review time of 626 days. The shortest average review time (221 days) was observed in the NMEs that used the combination of BTD + AA + PR (n = 23). Conclusions: FDA’s expedited pathways significantly reduce the regulatory review times for new molecular entities. Furthermore, NMEs that leveraged a combination of Breakthrough Therapy Designation, Accelerated Approval, and Priority Review achieved the shortest average review time of 221 days, 65% faster than drugs utilizing no expedited pathway, highlighting the potential benefit of utilizing multiple pathways concurrently.