Pathology Peer Review in Toxicology Studies: FDA Offers Q&A
The US Food and Drug Administration (FDA) on Wednesday released nine draft questions and answers to help sponsors and nonclinical laboratory staff manage and conduct pathology peer review 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,” the six-page draft says.
The agency defines pathology peer review as the second histopathological review of tissue samples during GLP-compliant toxicology studies, following the initial review by the study pathologist.
“Pathology peer review can be particularly useful in situations where unique or unexpected findings are noted or when the peer-review pathologist has a particular expertise with a class of compounds,” FDA explains.
The Q&A discusses what prospective (prior to the finalization of the study pathologist’s report) and retrospective peer review (after the finalization of the pathology report) mean, how pathology peer review can be conducted at a non-GLP compliant site and how the peer review should be documented.
“A formal pathology peer review should be planned, conducted, documented, and reported in accordance with established procedures. These procedures should be documented and available to the peer-review pathologist before initiation of the peer review and should be clearly described in the study protocol or study protocol amendments and in SOPs pertaining to the GLP studies,” the draft says.
FDA also discusses how to resolve differences in interpretation between the study pathologist and the peer review pathologist.
“The study pathologist is the individual responsible for the overall analysis and interpretation of the pathology data. If the peer-review pathologist does not concur with the study pathologist’s interpretations, then changes to the interpretations might be made by the study pathologist to reflect consensus with the peer-review pathologist. The difference in interpretation should be documented by the peer-review pathologist before engaging in a dialogue to resolve the interpretative differences. If no resolution can be reached, the study pathologist and peer-review pathologist should carefully follow a transparent and unbiased process that is clearly described in the testing facility’s SOPs for resolving interpretative differences during pathology peer review,” FDA says.
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers: Draft Guidance for Industry