Health Law Daily Wrap Up, CLINICAL RESEARCH—FDA GUIDANCE NOTICES: New guidance issued for ensuring safety and reliability in clinical trials, (Sep 9, 2025)

By WK Editorial Staff

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “E6(R3) Good Clinical Practice.”

The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes a principles document and annex 1 and is the precursory guidance to the draft guidance entitled “E6(R3) Good Clinical Practice: Annex 2.” Once complete, the guidance will be composed of a principles document, annex 1, and annex 2. The guidance is intended to outline flexible and modern good clinical practices for conducting clinical trials. Notably, the guidance highlights the importance of quality-by-design, proportionality, and risk-based approaches in conducting clinical trials to ensure safety and reliability of results. The guidance also encourages use of innovative design elements and technology in clinical trials, while avoiding unnecessary complexities. The guidance finalizes the draft guidance of the same title issued on June 7, 2023 (Notice, 90 Fed. Reg. 43460 (Sept. 9, 2025)).

Dates. The announcement of the guidance is published in the Federal Register on September 9, 2025.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews ClinicalNews DrugBiologicNews