US agencies take steps to expand alternatives to animal testing

The National Institutes of Health (NIH) announced $88 million for 10 construction projects across nine states on 21 September to advance alternatives to animal-based research. It also announced a competition offering more than $7 million in prizes for sensing technologies and plans for a laboratory combining human organoids, robotics and AI. The NIH says animal models remain an important research tool and aims to reduce their use where feasible. [4]

The Food and Drug Administration (FDA) announced a separate change to regulations covering safety testing before trials of drugs and biological products in people. Its direct final rule replaces references to “animal tests” and “animal studies” with broader “nonclinical” terminology, allowing validated non-animal methods to be used where appropriate. It does not ban animal studies or change evidentiary standards. [5]

Published on 22 September, the rule is scheduled to take effect on 4 February 2027. Comments are due by 7 December; the FDA says it will withdraw the rule if it receives significant adverse comments in time. The agency has also published a database with 25 examples of newer testing methods used in applications for approved drugs. [3] [5] [6]