Not for implementation. Contains non-binding recommendations.
Docket Number: FDA-2023-D-1955 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and ResearchThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “E6(R3) Guideline for Good Clinical Practice.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance outlines modernized Good Clinical Practice considerations to guide thoughtful design and responsible conduct of clinical trials in a manner that ensures participant safety and the reliability of trial results. This draft guidance encourages innovation, focuses on quality, and establishes proportionate and risk-based approaches for conducting clinical trials, while minimizing unnecessary complexities. The draft guidance is intended to provide flexible, modern, and clear Good Clinical Practice for conducting clinical trials
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All written comments should be identified with this document's docket number: FDA-2023-D-1955.