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In April 2025, the FDA announced plans to shift biomedical research for monoclonal antibodies and other medications away from animal testing toward new approaches.
One year later, much speculation remains regarding the impact this decision will ultimately have on research and development, prescribers and patients, and animal welfare.
“The FDA’s April 10, 2025, announcement was a clear signal that the agency wants human-relevant evidence, or new approach methods, to increasingly replace or reduce certain traditional animal studies, starting with monoclonal antibodies, through a stepwise approach