The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice
FDA Law Blog
FEBRUARY 27, 2025
Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. As stakeholders begin implementing R3, many questions remain regarding its practical application. By Julie Kim & Deborah L.
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