FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing

The U.S. Food and Drug Administration issued a new regulation allowing non-animal testing methods to be used for evaluating the safety of drugs and biological products intended for human use before human trials. The update reflects scientific and technological advances that have expanded testing options, including methods using human cells, organs-on-chips, and computer models. The regulation replaces terminology such as "animal tests" and "animal studies" with "nonclinical tests" and "nonclinical studies" in accordance with the Food and Drug Omnibus Reform Act of 2022 (FDORA). The new rules do not eliminate or prohibit animal testing, change evidence standards, or impose new costs on drug developers. The FDA simultaneously launched a database featuring 25 examples of practical applications of New Approach Methodologies (NAMs) from publicly available FDA review materials. These measures aim to support drug development using modern and more accurate methods that better reflect human biology.