The FDA launched a pilot program in 2025 allowing select drug developers to use non-animal methods like organ-on-a-chip systems and computer modeling instead of traditional animal testing. The NIH followed with its own initiative to expand human-based science.
In a major shift for pharmaceutical regulation, the U.S. Food and Drug Administration launched a pilot program in 2025 that allows select developers of monoclonal antibodies and other drugs to use non-animal-based strategies to prove their medications work. Instead of the traditional requirement to demonstrate efficacy in animal models, companies can now use computer modeling, organ-on-a-chip systems, and other advanced technologies to move toward human trials.
The National Institutes of Health quickly followed suit, announcing a new initiative to expand human-based science by deploying innovations in data science and technology. Advocates for animal welfare and scientific modernization hailed the moves as long overdue. "This represents a paradigm shift in how we develop medicines," said a leading bioethicist. The pilot programs are expected to accelerate drug development timelines, reduce costs, and improve the accuracy of predicting how drugs will behave in humans — since animal models often fail to translate to human outcomes.
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