Fast Facts: Serious Adverse Event Reporting Requirements in the US

Posted 22 March 2017 By Valerie Fauvelle, MS, RAC

placeholder+image This article presents reporting requirements for Serious Adverse Events (SAEs) and focuses on an important, but often overlooked regulation that specifies when a study is being run and includes the use of an approved drug. There are reporting requirements with specific timeframes that must be followed if there is a reportable SAE attributed to the approved drug.

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Categories: Biologics and biotechnology, Drugs, Clinical, Postmarket surveillance, Features, US, FDA

Tags: Adverse Event Reporting

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