Search results with tag "Ind safety reporting"

The Basics on Adverse Event Monitoring, Assessment and ...

AE Reporting for IND Studies –Significant updates to IND regs published in Federal Register 9/29/10 –New regs in effect 3/28/11 •Important implications for Sponsors and Investigators 9 •Final Rule on IND Safety Reporting –See 2/2010 FDA guidance and read updated IND regs.

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