GUIDANCE DOCUMENT
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Draft Guidance for Industry April 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2021-D-1268
- Docket Number:
- FDA-2021-D-1268
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Food Safety and Applied NutritionCenter for Tobacco ProductsOffice of Regulatory AffairsCenter for Veterinary Medicine
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.