BioCentury
ARTICLE | Product Development

Reduced animal testing could unlock host of benefits, but not overnight

FDA outlines three-year road map to reduce animal safety studies for mAbs

April 15, 2025 1:11 AM UTC

FDA’s plan to move away from animal tox testing is not new — it’s been decades in the making — but the moment might be right for accelerating progress. 

If done carefully, replacing animal models with human- or AI-based methodologies for assessing safety could benefit both biopharmas and patients, while helping the U.S. maintain its global position as a clinical research hub...

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