WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has announced that vit achieved its key first-year goals in the implementation of its April 2025 Roadmap to Reducing Animal Testing in Preclinical Safety Studies, marking one year of transformative action to modernize drug development through innovative, human-relevant science.
'One year ago, we issued an ambitious road map to eliminate unnecessary animal testing and replace animal testing with more precise ways of predicting drug safety in humans,' said FDA Commissioner Marty Makary. 'In addition to ushering in more scientifically accurate way to test drugs before they are used in humans, the agency has made great strides to reduce research and development costs, which will lower drug prices for everyday Americans'
From a scientific standpoint, animals are not a great model of how well drugs perform in humans. Historically, more than 90 percent of drugs that clear animal studies do not receive FDA approval, often due to safety or efficacy issues identified in human trials. To address this gap, FDA is advancing use of new approach methodologies - including advanced in vitro systems, computational modeling, and human-derived platforms-that better reflect human biology and improve prediction of drug effects.
Unlike previous guidance to industry, the FDA's 2025 road map strategy established specific time frames for phasing out animal testing where equivalent or better alternatives exist. Monday, the agency released a follow-up report summarizing the agency's progress in implementing the road map and clarifying its next steps.
Since issuing the road map, FDA has released draft guidance on the reduction or elimination of nonhuman primate testing in monoclonal antibody development; Updated guidance to support a transition from horseshoe crab-derived endotoxin testing, which could spare more than one million animals per year; and is working to reduce or eliminate animal used for FDA approval when drugs have demonstrated safety from their broad use in humans in other countries.
To sustain progress, FDA has deployed key infrastructure, including a permanent pathway for qualifying innovative drug development tools, cross-center scientific reviews, and a formal partnership with the National Institutes of Health, the agency said in a press release.
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