The Food and Drug Administration (FDA) on April 10 said it will be phasing out animal testing for monoclonal antibodies and other drugs.
FDA officials said that its animal testing requirement will be “reduced, refined, or potentially replaced” with other approaches, including advanced computer simulations utilizing artificial intelligence and lab-grown products that are designed to mimic human organs.
The agency will also start looking at preexisting, real-world safety data from other countries that have regulatory standards similar to those in the United States.
“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use,” FDA Commissioner Dr. Marty Makary said in a statement.
He said that the move “represents a major step toward ending the use of laboratory animals in drug testing.”
Companies that submit what the agency described as strong safety data from non-animal testing could receive faster review, according to the FDA.
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