US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018

Skydel, JJ; Zhang, AD; Dhruva, SS; Ross, JS; Wallach, JD

Wallach, JD (corresponding author), Yale Sch Publ Hlth, Dept Environm Hlth Sci, 60 Coll St,Floor 4,Room 411, New Haven, CT 06510 USA.

CLINICAL TRIALS, 2021; 18 (4): 488

Abstract

Background/Aims The US Food and Drug Administration outlines clinical studies as postmarketing requirements and commitments to be fulfilled following ......

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