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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Detalles Bibliográficos
Publicado en:Front Pharmacol
Main Authors: Liberti, Lawrence, Bujar, Magda, Breckenridge, Alasdair, Hoekman, Jarno, McAuslane, Neil, Stolk, Pieter, Leufkens, Hubert
Formato: Artigo
Idioma:Inglês
Publicado: Frontiers Media S.A. 2017
Assuntos:
Pharmacology
Acceso en liña: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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