FDA Provides Updated Draft Guidance To Support E6(R3)

by Jessica Cordes  - January 27, 2025

Guest Column | January 27, 2025

FDA Provides Updated Draft Guidance To Support E6(R3)

By Jessica Cordes, senior consultant, Clinical Excellence GmbH

In support of ICH E6(R3), which recently gained ICH approval but is not yet endorsed by regulators, the FDA has published draft guidance titled E6(R3) Good Clinical Practice: Annex 2, which emphasizes the importance of decentralized elements and the integration of real-world data. This article summarizes the key elements of the FDA’s recommendations.

Please read the full Clinical Leader Article.

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