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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Detalhes bibliográficos
Publicado no:Front Pharmacol
Main Authors: Liberti, Lawrence, Bujar, Magda, Breckenridge, Alasdair, Hoekman, Jarno, McAuslane, Neil, Stolk, Pieter, Leufkens, Hubert
Formato: Artigo
Idioma:Inglês
Publicado em: Frontiers Media S.A. 2017
Assuntos:
Pharmacology
Acesso em linha: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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