US FDA to Scale Back Primate Use in Some Drug Safety Tests

05:31 PM, 12/02/2025

The U.S. Food and Drug Administration has reportedly told drugmakers it will stop requiring laboratory monkeys for certain drug safety studies.

Some primate toxicity tests — which can last up to six months — may be shortened or dropped, though details and timing remain unclear.

There is no immediate independent verification or official comprehensive confirmation of the reported change.

The U.S. Food and Drug Administration has reportedly told drugmakers it will stop requiring laboratory monkeys for certain drug safety studies.

Some primate toxicity tests — which can last up to six months — may be shortened or dropped, though details and timing remain unclear.

There is no immediate independent verification or official comprehensive confirmation of the reported change.

The U.S. Food and Drug Administration has told drugmakers it will stop requiring the use of laboratory monkeys for certain safety studies, according to a recent report.

Under the change, some primate toxicity studies — tests that can run for up to six months — could be shortened or eliminated. The move appears aimed at reducing reliance on long-duration primate testing where alternative methods or additional data can meet safety requirements, though the specific tests affected and the timeline for implementation were not detailed.

There has been no immediate independent verification or official comprehensive statement confirming the full scope of the policy shift.

If implemented, the change could have implications for drug developers and animal-welfare advocates alike: companies may need to validate and adopt non-primate models or provide supplementary evidence to regulators, while proponents of reduced animal testing may see this as a step forward.

Reporting by Anusha Shah; Editing by Bernadette Baum.

US FDA to Scale Back Primate Use in Some Drug Safety Tests

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