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What does the FDA say about non-clinical digital pathology for GLP?
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Several scanners have been cleared by the FDA for clinical pathology work, but what about FDAs stand on all the nonclinical pathology work done in a regulatory environment? Specifically the work done in the Good Laboratory Practice (GLP) compliant environment?
- Can we use the slides without restrictions in lieu of glass slides?
- What part of the digital pathology system do we need to validate?
- How do wemaintain and archive the whole slide images used for the pathology portion of the nonclinical toxicologic studies?
Good news!
There is an official FDA draft guidance for the industry that asks all those and a few more questions and answers them at the same time.
In this episode I will go through the guidance for you, so that you don't have to spend time reading this document. But if you feel like doing it anyway, it's available for you to download below in this episode's resources.
And in case you want to skip the whole episode (which I sincerely hope you don't! Believe me, it's pretty fun for and FDA guidance episode:), the answer to most questions is YES.
Talk to you inside the episode!
This episode's resources:
- Use of Whole Slide Imaging in nonclinical Toxicology Studies: Questions and Answers. Draft Guidance for the Industry.
- Dr. Aleks Zuraw on TikTok :)
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