Histopathology Peer Review in Nonclinical Toxicology Studies

Recommended Actions

1. Establish written procedures (SOPs) for pathology peer review process
2. Ensure peer review pathologists have appropriate qualifications and training
3. Document peer review in study protocol or amendment
4. Implement measures to ensure independence and prevent undue influence
5. Create templates for peer review statements including all required information
6. Establish procedures for handling differences in interpretation
7. Maintain comprehensive documentation of peer review process and communications
8. Include signed peer review statements in final study reports
9. Create process for amendments when retrospective changes are needed
10. Establish record retention procedures for all peer review documentation

Key Considerations

Non-clinical testing

• Peer review can be conducted before finalization (contemporaneous) or after finalization (retrospective) of the study pathologist’s report
• Study pathologist must prepare written narrative of diagnoses before contemporaneous peer review
• Changes from retrospective review must be documented in amendments
• Peer review process must be included in study protocol or amendment
• Written procedures must guide the review process
• Peer review can be conducted at non-GLP sites if study integrity is protected

Other considerations

• Peer-review pathologist must have appropriate education, training and experience
• Peer review statement must be signed and dated, including specific required information
• Process must be transparent and free from undue influence
• Differences in interpretation must be addressed through documented procedures
• All communications regarding differences of opinion must be retained
• Final study report must include signed peer review statement

  Relevant Guidances

• Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects
• Good Laboratory Practice (GLP) Requirements for Non-Clinical Laboratory Studies
• Use of Whole Slide Imaging in GLP Nonclinical Toxicology Studies

Related references and norms

• 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies

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Original guidance

• Histopathology Peer Review in Nonclinical Toxicology Studies
• HTML / PDF
• Issue date: 2021-12-27
• Last changed date: 2024-10-01
• Status: FINAL
• Official FDA topics: Tobacco, Medical Devices, Food & Beverages, Pharmacology/Toxicology, Drugs, Animal & Veterinary, Biologics
• ReguVirta summary file ID: cb8f1f9512ddf28d4bd043abe3f94b70