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Liberti L, Bujar M, Breckenridge A, et al. FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines. Front Pharmacol. 2017;8:161doi: 10.3389/fphar.2017.00161.
Liberti, L., Bujar, M., Breckenridge, A., Hoekman, J., McAuslane, N., Stolk, P., & Leufkens, H. (2017). FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines. Frontiers in pharmacology, 8161. https://doi.org/10.3389/fphar.2017.00161
Liberti, Lawrence, et al. "FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines." Frontiers in pharmacology vol. 8 (2017): 161. doi: https://doi.org/10.3389/fphar.2017.00161
Liberti L, Bujar M, Breckenridge A, Hoekman J, McAuslane N, Stolk P, Leufkens H. FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines. Front Pharmacol. 2017 Apr 03;8:161. doi: 10.3389/fphar.2017.00161. eCollection 2017. PMID: 28420989; PMCID: PMC5376616.
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Front Pharmacol. 2017 Apr 03;8:161. doi: 10.3389/fphar.2017.00161. eCollection 2017.

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

Frontiers in pharmacology

Lawrence Liberti, Magda Bujar, Alasdair Breckenridge, Jarno Hoekman, Neil McAuslane, Pieter Stolk, Hubert Leufkens

Affiliations

  1. Centre for Innovation in Regulatory ScienceLondon, UK.
  2. Utrecht Institute for Pharmaceutical Sciences, Utrecht UniversityUtrecht, Netherlands.
  3. School of Life Sciences, University of LiverpoolLiverpool, UK.
  4. Innovation Studies Group, Copernicus Institute for Sustainable Development, Utrecht UniversityUtrecht, Netherlands.

PMID: 28420989 PMCID: PMC5376616 DOI: 10.3389/fphar.2017.00161

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,

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

References

  1. J Public Health Policy. 2016 Mar 10;:null - PubMed
  2. Clin Pharmacol Ther. 2016 Dec;100(6):603-605 - PubMed

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