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...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
University of Minnesota Libraries Publishing
2017-02-01
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| Series: | INNOVATIONS in Pharmacy |
| Subjects: | |
| Online Access: | https://pubs.lib.umn.edu/index.php/innovations/article/view/495 |