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The FDA is replacing “animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods.”
According to the FDA, “The FDA’s animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (so-called New Approach Methodologies or NAMs data).”
Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods. The new approach is designed to improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development (R&D) costs, and ultimately, drug prices.
The FDA’s animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (so-called New Approach Methodologies or NAMs data). Implementation of the regimen will begin immediately for investigational new drug (IND) applications, where inclusion of NAMs data is encouraged, and is outlined in a roadmap also being released today. To make determinations of efficacy, the agency will also begin use pre-existing, real-world safety data from other countries, with comparable regulatory standards, where the drug has already been studied in humans.
“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,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “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.”
PETA thanked the Trump administration for the move.
They wrote, “PETA thanks the Trump administration for modernizing the FDA and helping spare tens of thousands of animals each year from being killed in expensive and archaic laboratory tests.”
The White House Press Secretary is highlighting this milestone!
PETA thanks the Trump administration for modernizing the FDA and helping spare tens of thousands of animals each year from being killed in expensive and archaic laboratory tests. https://t.co/unLYYNplMh
— PETA (@peta) April 14, 2025
PETA, which has blasted health officials such as Dr. Anthony Fauci for past animal testing, released a positive statement in response to the Trump administration’s recent policy directives.
“PETA applauds the FDA’s decision to stop harming animals and adopt human-relevant testing strategies for evaluating antibody therapies,” PETA senior vice president Kathy Guillermo said.
“It’s a significant step towards meeting the agency’s commitment to replace the use of animals – which PETA has worked hard to promote. All animal use, including failed vaccine and other testing on monkeys at the federally-funded primate centers, must end, and we are calling on the FDA to further embrace 21st-century science,” the statement continued.
Even PETA is backing one of Trump’s policies!