USA – FDA final guidance clarifies whole slide imaging expectations in nonclinical toxicology studies

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…