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GUIDANCE DOCUMENT

Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers July 2019

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
2019-16361
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, 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.


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Dockets Management
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Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-16361 .