The US Food and Drug Administration (FDA) on Tuesday issued final guidance on the use of whole slide imaging in nonclinical toxicology studies. The guidance is in a question-and-answer format and addresses issues such as validating the whole slide imaging system and protecting the integrity of the images captured.
“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 [good laboratory practice] GLP regulations,” the guidance states.
Histopathological assessment of tissues samples using whole slide imaging is a major part of nonclinical laboratory studies that can help sponsors and regulators understand the toxicology of a drug…
