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. 2019 Nov 1;179(11):1590-1592.
doi: 10.1001/jamainternmed.2019.3066.

Association Between Data Sources and US Food and Drug Administration Drug Safety Communications

Noam Tau  1   2 , Tzippy Shochat  3 , Anat Gafter-Gvili  2   4 , Ariadna Tibau  5 , Eitan Amir  6 , Daniel Shepshelovich  2   4
Affiliations

Association Between Data Sources and US Food and Drug Administration Drug Safety Communications

Noam Tau et al. JAMA Intern Med. .

Abstract

This study describes sources of initial safety signals that that preceded US Food and Drug Administration (FDA) drug safety communications and examines their associations with drug characteristics and subsequent label changes.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Amir reported personal fees from Genentech/Roche, personal fees from Apobiologix, personal fees from Agendia, and personal fees from Myriad Genetics outside the submitted work. No other disclosures were reported.

References

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