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GUIDANCE Final

E6(R3) Good Clinical Practice — Final Guidance for Industry

FDA · 2025 U.S. Food & Drug Administration
ABSTRACT — EDITORS' SUMMARY

FDA adoption of ICH E6(R3) as enforceable guidance, effective September 2025. The principles and Annex 1 become the operating instructions for U.S. sponsors.

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METADATA
TypeGUIDANCE
Year2025
VersionFinal
StatusCurrent
FormatPDF
Pages86
Size2.1 MB
Last reviewedSEP 2025
SOURCE
PDF · CANONICAL LINK https://www.fda.gov/media/169090/download ↗
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