Article

U.S. Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018

2020-09-02

Abstract excerpt

<h4>Background/Aims</h4> The U.S. Food and Drug Administration (FDA) outlines clinical studies as postmarketing requirements and commitments to be fulfilled following FDA approval of new drugs and biologics (“therapeutics”). As regulators have increasingly emphasized lifecycle evaluation of approved therapeutics, postmarketing studies are intended to advance our understanding of therapeutic safety and efficacy, ye...

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Literature Corpus work: f76b60d9-4521-5520-910c-d55f8284659b
DOI: 10.1101/2020.08.31.20184184

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