Issue Date: December 27, 2021
Issued by: Center for Biologics Evaluation and Research
Topic(s): Pharmacology/Toxicology
Status: Final
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
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: • Pathology Peer Review Guidance Snapshot • Pathology Peer Review Guidance Recap Podcast • Pathology Peer Review Guidance Recap Podcast Transcript
Download the Guidance Document
