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On Tuesday, June 7th, BIO submitted comments in response to the FDA’s draft guidance concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies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.
On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which…
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit…
On Wednesday, September 28th, BIO submitted comments to the Food & Drug Administration on the ICH Q2(R2) Guideline: Validation of Analytical Procedures and the ICH Q14 Guideline: Analytical Procedure Development. In addition to a number of…
On Tuesday, June 7th, BIO submitted comments in response to the FDA’s draft guidance concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies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.