FDA Takes Aim at Animal Testing With New Monoclonal Antibody Guidelines
On December 2, 2025, the U.S. Food and Drug Administration (FDA) issued a new draft guidance that could significantly reshape how drug developers conduct nonclinical testing for monoclonal antibodies. Titled “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies Guidance for Industry,” the document marks one of the agency’s most consequential steps yet toward reducing—and potentially replacing—animal testing […]
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