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BIO Comments on FDA Guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies

June 7, 2022

On Tuesday, June 7th, BIO submitted comments in response to the FDA’s draft guidance concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies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 GLP regulations. Importantly, this regulatory guidance was the first to ever specifically address the use of whole slide images in lieu of glass slides for nonclinical studies. In the comments submitted, BIO recommended the language be revised to align with the terminology widely used in the field of toxicologic pathology today. BIO also offered additional details that would increase the guidance’s instructive value for sponsors. Lastly, BIO broadly suggested that highlighting whether a particular tool and/or process results in the generation of raw data could provide a useful method for clearly outlining the proper approach sponsors should take in handling/documenting various practices associated with the use of WSI for nonclinical toxicology studies.

Download Full Comments Below
BIO Comments_FDA-2021-D-1268
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