Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers." When final, this guidance will represent FDA's current thinking on the use of whole slide images during good laboratory practice (GLP)-compliant toxicology studies using non-human specimens. When whole slide images are used as part of a nonclinical study conducted in compliance with the GLP regulations, adequate documentation is critical. 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.