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Home » Most Safety-Inspired Labeling Changes Aren’t Supported by Published Studies, Study Finds
Most Safety-Inspired Labeling Changes Aren’t Supported by Published Studies, Study Finds
Less that a third of regulatory actions spurred by safety signals in the FDA Adverse Event Reporting System (FAERS) weresupported by published studies, with most actions relying instead on case reports and none corroborated by FDA’s Sentinel Initiative, researchers at Yale University reported in the journal BMJ.