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GUIDANCE DOCUMENT

Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers December 2021

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2019-D-2330
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Veterinary Medicine
Center for Devices and Radiological Health
Center for Food Safety and Applied Nutrition
Center for Drug Evaluation and Research

This guidance provides information to sponsors and nonclinical laboratory staff regarding the management and conduct of pathology peer review performed during good laboratory practice (GLP)-compliant toxicology studies. When conducted, pathology peer review should be well-documented. However, documentation practices during pathology peer review have not been clearly defined and vary among nonclinical testing facilities. This question-and-answer document is intended to clarify FDA’s recommendations concerning the management, conduct, and documentation of pathology peer review.

Additional Guidance Resources:

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