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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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| Pubblicato in: | Front Pharmacol |
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| Autori principali: | , , , , , , |
| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
Frontiers Media S.A.
2017
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| Soggetti: | |
| Accesso online: | 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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