US FDA rule to improve reporting of safety information in drug trials

This article was originally published in SRA

30 Sep 2010
News

Vibha Sharma @ScripRegVibha vibha.sharma@informa.com

Executive Summary

The US Food and Drug Administration has issued a new rule that is aimed at expediting and improving the quality of safety reports provided by companies during clinical trials of investigational drugs and biologics^1-3.

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US FDA rule to improve reporting of safety information in drug trials

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