FOOD-AND-DRUG-ADMINISTRATION RISK ASSESSMENT - PROCESS AND TOXICOLOGIC PATHOLOGY

A general outline of the risk assessment process at the Center for Foo d Safety and Applied Nutrition (CFSAN) of the Food and Drug Administra tion based on the toxicologic evaluation of data is described. Example s of recent pathology evaluations are presented to illustrate primaril y the pathology review process at the CFSAN. These examples include th e review of data from rodent studies from proposed indirect food addit ives and data from dog studies submitted in support of an investigatio nal new drug, a shea-acting opioid, proposed as an anesthetic in human s.