FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines
نویسندگان
چکیده
منابع مشابه
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 combination of two or more FRPs influenced development and approval times. We developed a "metro map" to il...
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ژورنال
عنوان ژورنال: Frontiers in Pharmacology
سال: 2017
ISSN: 1663-9812
DOI: 10.3389/fphar.2017.00161