Bigstock The U.S. Food and Drug Administration (FDA) has issued a direct final rule clarifying that non-animal methods may be used, when appropriate, to evaluate the safety of drugs and biological products intended for human use before clinical trials. The rule reflects advances in New Approach Methodologies (NAMs), including human cell-based systems, organ-on-chip technologies, computer models and other tools designed to better reflect human biology. It updates regulatory terminology, replacing terms such as “animal tests” and “animal studies” with “nonclinical tests” and “nonclinical studies.” For veterinary professionals involved in research, comparative medicine or drug development, the changes signal a broader shift in how evidence used for human drug safety may be generated. The FDA said the rule does not prohibit animal studies, alter evidentiary standards, or require developers to adopt non-animal methods. Instead, animal studies and validated alternatives may be used according to the scientific question and regulatory needs. The agency has also launched a database of NAM use cases, initially containing 25 examples from publicly available FDA review materials. The resource is intended to demonstrate how newer testing approaches have been applied in regulatory settings. NAMs may be used when adequately validated and appropriate for the product and regulatory question. The FDA said recognizing these approaches could reduce uncertainty for developers preparing nonclinical evidence for clinical-trial applications while advancing regulatory science. The agency is accepting public comments on the rule. If significant adverse comments are received, the FDA may withdraw the direct final rule and proceed with its concurrently published proposed rule through the standard notice-and-comment process. For more information, visit the FDA website.
