Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014

Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC). The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between J...

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Main Authors: Benjamin Hixon (Author), Joseph M. Lowrey (Author), Lindsay N Hume (Author), Katelynn Mayberry (Author), Maisha Kelly Freeman (Author)
Format: Book
Published: University of Minnesota Libraries Publishing, 2017-02-01T00:00:00Z.
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3rd Floor Main Library

Holdings details from 3rd Floor Main Library
Call Number: A1234.567
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