Review of pathology data for regulatory purposes

This paper describes the review process for pathology data submitted to the Division of Pathology, Center for Food Safety and Applied Nutrition of the Food and Drug Administration. The Division of Pathology independently evaluates the pathology data submitted in support of the safety of a given compound. The submissions are examined for agreement between summarized information and data from individual animals, appropriateness of terminology applied to lesions, and adequacy of information (distribution and severity of observed lesions). Problems and concerns encountered during review sometimes require examination of microscopic slides. The slide review provides an independent characterization of the lesions and a verification of their incidence. We present some problems commonly encountered in our review of the pathology data and describe some recent pathology evaluations. Finally, we suggest some considerations for reporting pathology data that may facilitate regulatory review.