US FDA moves to curtail primate testing in drug trials

3/12/2025 6:32

The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical toxicity studies for certain monoclonal antibodies.



The agency said the shift would help cut development times and reduce research and development costs, which could translate into lower drug prices.



Under current FDA requirements for monoclonal antibodies, companies conduct studies in animals to test for any harmful effects of a drug.



A typical preclinical program for a monoclonal antibody could involve more than 100 non-human primates, at a cost of roughly $50,000 per animal, the agency said.