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US FDA moves to curtail primate testing in drug trials
The FDA's draft guidelines allow alternative human-relevant models and risk assessments to reduce primate testing and lower drug development costs, Commissioner Makary said.
- Dec 2 a U.S. regulatory agency published draft guidance to reduce primate testing for monoclonal antibodies using alternative models.
- The agency signaled this change earlier this year as part of initiatives under Martin Makary, FDA Commissioner, to streamline development and lower drugmaker costs amid competition from China's biotech sector.
- Typically about 100 macaque monkeys are used in such programs, costing roughly $50,000 per animal, and primate testing lasting up to six months can be reduced with organoid systems and laboratory off-tissue binding tests.
- The FDA launched a voucher program awarding 15 fast passes and expanded AI initiatives this week, while outlining a less-burdensome pathway for ultra-rare disease drugs.
- Officials say the change should shorten development timelines and lower research and development costs, which could reduce primate use, improve animal welfare, and boost global competitiveness in drug development.
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FDA Moves to Curb Monkey Testing for Monoclonal Antibody Products
In addition to benefitting Americans by lowering the cost to develop new pharmaceuticals, the move will also help make the US more competitive with China. The post FDA Moves to Curb Monkey Testing for Monoclonal Antibody Products first appeared on Le·gal In·sur·rec·tion.
FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies
Today, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining specific product types for which the FDA believes six-month non-human primate toxicity testing can be eliminated or reduced.
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