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
Autores principales: Liberti, Lawrence, Bujar, Magda, Breckenridge, Alasdair, Hoekman, Jarno, McAuslane, Neil, Stolk, Pieter, Leufkens, Hubert
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2017
Materias:
Pharmacology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5376616/
https://www.ncbi.nlm.nih.gov/pubmed/28420989
http://dx.doi.org/10.3389/fphar.2017.00161

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5376616/
https://www.ncbi.nlm.nih.gov/pubmed/28420989
http://dx.doi.org/10.3389/fphar.2017.00161

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