Open AccessComparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018
Author(s) -
Joshua D. Wallach,
Reshma Ramachandran,
Till Brückner,
Joseph S. Ross
Publication year - 2021
Publication title -
jama network open
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.278
H-Index - 39
ISSN - 2574-3805
DOI - 10.1001/jamanetworkopen.2021.33601
Subject(s) - food and drug administration , medicine , duration (music) , clinical trial , drug , drug trial , pharmacology , intensive care medicine , art , literature
This cross-sectional study compares the duration of postapproval trials with that of the pivotal trials used as the basis for the US Food and Drug Administration’s (FDA’s) approval for all indications receiving accelerated approval from 2009-2018.
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