2023-11211: Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers." This guidance represents FDA's current thinking on the use of whole slide images during good laboratory practice (GLP)-compliant toxicology studies. Documentation practices during generation, use, and retention of whole slide images have not been clearly defined and vary among nonclinical testing facilities. This question-and-answer document is intended to clarify FDA's recommendations concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies conducted in compliance with the GLP regulations. This guidance finalizes the draft guidance of the same title issued on April 8, 2022.
The agency’s own summary, as published.
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