August 2017 Slide of the Month

“Metro Map” analysis of FDA facilitated regulatory pathways and their influence on median approval times.

  • 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).
  • 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 C PR C AA) to 3,515 days (PR).
  • A “metro map” illustrates the relationship between the key aspects of each facilitated regulatory pathway (FRP), the touch points and temporal relationship among them, and the length of the regulatory review times when these programs were employed.
  • The key steps for each of the four programmes are illustrated, from pre-IND through to post-authorisation. The process begins at the upper left region addressing factors related to acceptance and the product’s characteristics. A product may then follow one of several pre-designation routes to a point at which a designation is assigned (a standard review is always an option and therefore is not illustrated here).
  • The combination of FRP routes result in varying approval times, designated by the tracks in the Review Period sector. The relative length of the review period line corresponds to the median review time; the “node” size at the end of the line reflects the number of products that followed that route.

Reprinted from Liberti L, Bujar M, Breckenridge A et al. FDA Facilitated regulatory pathways: Visualizing their characteristics, development, and authorization timelines. Frontiers Pharmacol. 2017;8:161.  Available for free download at http://journal.frontiersin.org/article/10.3389/fphar.2017.00161/full

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