Nonclinical-Studies

Rise for Animals analyzes the FDA’s September 21, 2026 direct final rule replacing “animal tests” and “animal studies” with “nonclinical tests” and “nonclinical studies,” arguing the rule is meaningful but reversible and urging passage of the FDA Modernization Act 3.0 to give the change statutory force.

The U.S. Food and Drug Administration issued a direct final rule clarifying that non-animal methods can be used, where appropriate, to test the safety of drugs and biological products before human trials, and launched a database of 25 examples of New Approach Methodologies in drug review.