The FDA will begin replacing animal testing in the development of monoclonal antibody therapies and other drugs with human-based methods.
The agency said the new approach will aim to improve drug safety, speed up the evaluation process, reduce the use of animal testing, lower research and development costs and help bring down drug prices, according to an April 10 news release from the FDA.
Animal testing requirements will be “reduced, refined, or potentially replaced” with methods such as AI-based toxicity modeling and lab testing using human cell lines and organoids. The New Approach Methodologies will be accepted in investigational new drug therapies starting immediately.
The FDA said it will promote the use of software models that simulate how a drug moves through the human body, predict side effects and encourage the use of lab-grown human tissues and organ systems for safety testing.
The agency is coordinating this effort with federal bodies that include the National Institutes of Health, the National Toxology Program and the Department of Veterans Affairs.
