FIRST ON FOX — The Food and Drug Administration is phasing out an animal testing requirement for antibody therapies in favor of testing drugs on “lab-grown human ‘organoids,’” the FDA announced on Thursday.
“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, said in comment provided to Fox News Digital.
“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.”
The phase-out focuses on ending animal testing in regard to researching monoclonal antibody therapies, which are proteins made in a lab that are meant to stimulate your immune system to fight diseases such as cancer.
Instead, according to the FDA’s press release obtained by Fox Digital, the FDA will test on “organoids,” which are artificially grown masses of cells.
“The FDA will promote the use of lab-grown human ‘organoids’ and organ-on-a-chip systems that mimic human organs – such as liver, heart, and immune organs – to test drug safety. These experiments can reveal toxic effects that could easily go undetected in animals, providing a more direct window into human responses,” the press release says.
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