FDA Provides Guidance on Histopathology Review for Non-clinical Studies
(Thursday, January 13, 2022)
A detailed histopathology is usually a critical part of a non-clinical toxicology study as it can indicate risk not obvious from observations of physical symptoms and could be used to evaluate long-term risk of an investigational product (IP). Often the study pathologist reviewing the data might need an independent assessment of abnormal findings to confirm the abnormality and assure accurate interpretation. Such independent assessment, called pathology peer review, could provide valuable information about the IP’s risk. FDA’s guidance released a few weeks ago provides a formal opinion regarding best practices for pathology peer reviews. In general, FDA is quite open to how the peer review is conducted. For example, FDA is fine with the peer review be done under non-GLP quality systems, such as by consulting independent pathologists. However, FDA, not surprisingly expects that the peer review be done under SOPs and detailed records be generated describing the assessments of the pathology peer reviewer and any changes made to the interpretations of the study based on such review. The peer review cannot be anonymous; the peer reviewers’ credentials, findings, and conclusions must be properly documented and included in the final report submitted to the FDA. The guidance almost provides a template for the SOPs for the Pathology Peer Reviews by a non-clinical testing facility and should be a quality check for sponsors of non-clinical studies.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC