MONDAY, April 14, 2025 (HealthDay News) — The U.S. Food and Drug Administration announced it is shifting away from animal testing in the development of monoclonal antibody therapies and other drugs, favoring more effective, human-relevant methods.
The new strategy aims to enhance drug safety and expedite the evaluation process. It also seeks to decrease animal experimentation, lower research and development costs, and as a result, reduce drug prices.
To achieve these ends, the FDA will use computer modeling and artificial intelligence (AI) to predict a drug’s behavior and promote the use of lab-grown human organoids (tiny, self-organized three-dimensional tissue cultures derived from stem cells) and organ-on-a-chip systems that mimic human organs to test drug safety.
The new regimen is set to launch immediately for investigational new drug applications. To assess efficacy, the agency will start utilizing preexisting, real-world safety data from countries with comparable regulatory standards, where the drug has already undergone human studies.
“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 Martin A. Makary, M.D., M.P.H., said in a statement. “By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices. It is a win-win for public health and ethics.”
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