Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers." This draft guidance represents FDA's current thinking on the management and conduct of pathology peer review performed during good laboratory practice (GLP)- compliant toxicology studies. When pathology peer review occurs as part of a nonclinical laboratory study conducted in compliance with GLP regulations, it 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 This question-and-answer (Q&A) draft guidance is intended to clarify FDA's recommendations concerning the management, conduct, and documentation of pathology peer review.