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GUIDELINE Step 4 Final

E2F Development Safety Update Report

E2F International Council for Harmonisation
ABSTRACT — EDITORS' SUMMARY

The DSUR standard — periodic safety reporting on drugs under development. Referenced by E6(R3) §3.13 for sponsor safety reporting obligations.

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METADATA
TypeGUIDELINE
Year2011
VersionStep 4 Final
StatusCurrent
FormatPDF
Pages
Size
Last reviewedSEP 2011
SOURCE
PDF · CANONICAL LINK https://database.ich.org/sites/default/files/E2F_Guideline.pdf
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