Tox Study Whole Slide Imaging Guidance

FDA has published a question-and-answer guidance, Use of Whole Slide Imaging in Nonclinical Toxicology Studies, with information for sponsors and nonclinical laboratories on 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. The document does not cover the use of whole slide imaging in clinical applications.

“FDA’s expectations regarding documentation practices during the generation, use, and retention of whole slide images have not been clearly defined and vary among nonclinical testing facilities,” the guidance says. “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.”