The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation
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DOI: 10.1177/1740774518770657
Abstract: When the editors of Clinical Trials solicited our review on the U.S. Food and Drug Administration’s (FDA) expedited development and review programs, we anticipated there would be accompanying commentaries from other academics with differing opinions,… read more here.
Keywords: approval programs; expedited approval; evidence; food drug ... See more keywords