Apply AI model to drug development and phase out animal testing... FDA Announces Cost Reduction and Animal Welfare Measures

Apr 11, 2025

Apply AI model to drug development and phase out animal testing... FDA Announces Cost Reduction and Animal Welfare Measures
◇FDA headquarters in White Oak, Maryland, United States. REUTERS Yonhap News



The U.S. Food and Drug Administration (FDA) announced on the 10th (local time) that it plans to replace animal testing with a new model based on artificial intelligence (AI). This approach, which will be applied to the development of monoclonal antibody treatments and other drugs, is designed to improve drug safety and accelerate the evaluation process, while reducing animal testing, lowering R&D costs, and ultimately lowering drug prices.

FDA Commissioner Martin Maccari said, "This action marks a fundamental turning point in the way drugs are evaluated, and presents the potential to reduce animal use while providing fast and effective treatments to the American people."This approach provides faster and more reliable treatments, and reduces R&D costs and drug prices, which are beneficial both in terms of public health and ethics."

Animal testing will be reduced, improved or potentially replaced using New Approach Methods (NAMs), a new methodology that uses AI-based models to predict drug action and side effects and includes testing on lab-made human organ-like structures, the FDA explained.




The FDA plans to accelerate the verification and introduction of such innovative methods in cooperation with the National Institute of Health (NIH) and the National Toxic Program (NTP). Within this year, a public workshop will be held to discuss roadmaps and gather stakeholder input, with plans to launch a pilot (sample) program next year that will allow some antibody-based drug developers to use non-animal-based testing strategies. The FDA predicted that companies submitting strong safety data through non-animal testing will be able to undergo a simplified review, which will spur investment in the latest testing platforms.

Director Macari said "Patients are provided with a more efficient new drug pipeline, and there are also safety benefits. It will also be a significant turning point in terms of animal welfare" he said.






This article was translated by Naver AI translator.