New strategy aims to enhance drug safety, expedite evaluation process, and decrease animal experimentation<\/p>\n<\/h3>\n
By Stephanie Brown HealthDay Reporter<\/b>
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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.<\/p>\n
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.<\/p>\n
To achieve these ends, the FDA will use computer modeling and artificial intelligence (AI) to predict a drug\u2019s 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.<\/p>\n
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.<\/p>\n
“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.”<\/p>\n