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

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers." This guidance represents FDA's current thinking on the management and conduct of pathology peer review performed during good laboratory practice (GLP)-compliant toxicology studies. This guidance finalizes the draft guidance "Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers" issued on September 30, 2019. This revision includes editorial changes to improve the clarity of the document.