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

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 combinatio...

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Bibliografiska uppgifter
I publikationen:Front Pharmacol
Huvudupphovsmän: Liberti, Lawrence, Bujar, Magda, Breckenridge, Alasdair, Hoekman, Jarno, McAuslane, Neil, Stolk, Pieter, Leufkens, Hubert
Materialtyp: Artigo
Språk:Inglês
Publicerad: Frontiers Media S.A. 2017
Ämnen:
Pharmacology
Länkar:https://ncbi.nlm.nih.gov/pmc/articles/PMC5376616/
https://ncbi.nlm.nih.gov/pubmed/28420989
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3389/fphar.2017.00161
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