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. 2017 Apr 3:8:161.
doi: 10.3389/fphar.2017.00161. eCollection 2017.

FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines

Lawrence Liberti  1   2 , Magda Bujar  1 , Alasdair Breckenridge  3 , Jarno Hoekman  2   4 , Neil McAuslane  1 , Pieter Stolk  2 , Hubert Leufkens  2
Affiliations

FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines

Lawrence Liberti et al. Front Pharmacol. .

Abstract

The US Food and Drug Administration (FDA) has four facilitated regulatory pathways (FRPs): Fast Track (FT), Breakthrough Therapy (BTD), Priority Review (PR), and Accelerated Approval (AA). Only PR specifies an expedited review timeline (6 months). We sought to determine to what extent the combination of two or more FRPs influenced development and approval times. We developed a "metro map" to illustrate FRP elements and their influence on review times. We assessed 125 new active substances (approved January 2013 to December 2015) 74 of which used one or more FRPs. For these 74, development times ranged from 1,458 (BTD + PR + AA) to 3,515 days (PR). PR alone had a median approval time of 242 days. The most common combination was FT + PR (median approval 292 days, n = 21). The fastest approval times were for PR + FT + BTD + AA (145 days) and PR + BTD + AA (166 days). Our findings support the combination of FRPs for shortening development and review times beyond that provided by PR alone.

Keywords: Accelerated Approval; Breakthrough Therapy; FDA; Fast Track; Priority Review; facilitated regulatory pathway; review times.

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Figures

FIGURE 1
FIGURE 1
“Metro Map” analysis of FDA FRPs and influence on median approval times.
FIGURE 2
FIGURE 2
Median development times (IND to NDA submission) for products that followed one or more FRPs.
FIGURE 3
FIGURE 3
Median time for FDA approvals for products that followed one or more FRPs.
See this image and copyright information in PMC

References

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