Business Talk

FDA finalizes guidance on whole slide imaging approaches for nonclinical studies

Just over a year after issuing draft guidance on the topic, FDA has finalized its thinking regarding the use of whole slide imaging (WSI) in nonclinical toxicology studies. While the final guidance document reflects relatively minor changes from its predecessor, the broader field of digital pathology continues to undergo rapid innovation that warrants careful regulatory consideration.

Background: nonclinical research and pathology

When pharmaceutical and biopharmaceutical companies are in the early stages of testing a product, they rely on nonclinical assessments meant to demonstrate that the product will likely be safe (and effective) in humans.

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