FDA Pushes for Reduced Animal Testing in Drug Advancement, Embracing New Approach Methodologies
the U.S. Food and Drug Governance (FDA) is actively encouraging the use of New Approach Methodologies (NAMs) in preclinical drug safety and efficacy studies, signaling a significant shift away from traditional animal testing. This initiative aims to reduce the reliance on animal models, wiht a long-term goal of making animal testing the exception rather than the rule within the next five years.
NAMs encompass a range of innovative techniques that can augment or replace animal studies.These include in silico methods, which leverage computational models, artificial intelligence (AI), and machine learning to predict a compound’s pharmacokinetic and pharmacodynamic properties. Such models can forecast a drug’s absorption, distribution, metabolism, and excretion, while AI can further predict immunogenicity and potential on- and off-target effects.
Beyond computational approaches, NAMs also involve the utilization of organ donation and tissue preservation for ex vivo testing, as well as transgenic animal testing. These methods are designed to provide more accurate predictions of a drug’s safety and efficacy in humans. The FDA is also open to combinational approaches that integrate various NAMs.
To facilitate this transition, the FDA is incentivizing the submission of NAM data by potentially reducing the duration or types of animal data required when accompanied by NAMs. The agency plans to collaborate with key stakeholders to establish clear, reproducible guidelines for the appropriate use of NAMs, ensuring the rigor and continuity of existing drug development standards. This strategic move is supported by legislative efforts, such as the Consolidated Appropriations Act of 2023, which also promotes the advancement of NAMs.
References:
- FDA drug approval process infographic (horizontal). FDA. Updated February 26, 2016. Accessed June 19, 2025.https://www.fda.gov/drugs/data-consumers-and-patients-drugs/fda-drug-approval-process-infographic-horizontal
- Consolidated Appropriations Act of 2023, HR 2617, 117th Cong (2023).Accessed June 23, 2025. https://www.congress.gov/bill/117th-congress/house-bill/2617
- FDA announces plan to phase out animal testing requirements for monoclonal antibodies and other drugs. News release. FDA.April 10, 2025. Accessed June 19, 2025. https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs
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- Roadmap to reducing animal testing in preclinical safety studies. FDA. Accessed June 19, 2025. https://www.fda.gov/media/186092/download?attachment
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