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GUIDANCE DOCUMENT

Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Guidance for Industry May 2023

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2021-D-1268
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Inspections and Investigations
Human Foods Program

This guidance provides information to sponsors and nonclinical laboratories regarding the use and management of whole slide images used during histopathology assessment and/or pathology peer review performed for good laboratory practice (GLP)-compliant nonclinical toxicology studies using non-human specimens.2 When whole slide imaging is used as part of a nonclinical 20 study conducted in compliance with the GLP regulations, adequate documentation is critical. The FDA’s expectations regarding 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 imaging in histopathology assessment and/or pathology peer review for nonclinical studies conducted in compliance with the GLP regulations.

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