Agency outlines updated approach for certain monoclonal antibody studies.
The Food and Drug Administration (FDA) recently released a draft guidance proposing reduced reliance on non-human primates in “preclinical toxicity” testing for certain monoclonal antibody drugs. Under current practices, drug developers often use large numbers of laboratory monkeys in studies that can last up to six months and cost tens of thousands of dollars per animal.
“Modern science has given us far more effective and humane ways of evaluating drug safety than animal testing,” FDA Commissioner Marty Makary stated.
The agency plans to expand the use of risk assessments that incorporate computational models, organoid systems, and real-world human safety data rather than extended animal testing. FDA officials said the approach seeks to modernize drug evaluation while maintaining safety standards and could reduce development timelines and research costs.
As the Lord Leads, Pray with Us…
- For Commissioner Makary to be led by the Lord as he heads the Food and Drug Administration.
- For FDA officials and researchers as they balance scientific innovation with patient safety.
- For wisdom for Secretary Kennedy and HHS leaders as they seek to reduce timelines and costs of drug testing.
Sources: Food and Drug Administration, Reuters
