Placeholder Banner

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On Tuesday, June 7th, BIO submitted comments in response to the FDA’s draft guidance concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies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
Discover More
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments regarding the request for information and comments on the Food and Drug Administration's Draft Report and Plan on Best Practices…
On behalf of its member companies and organizations, the Biotechnology Innovation Organization (“BIO”) extends its appreciation to NIST for considering these comments in response to the agency’s Draft Interagency Guidance Framework for Considering…