The U.S. Food and Drug Administration said on Thursday it plans to replace animal testing in the development of monoclonal antibody therapies and other drugs with "human-relevant methods," including the use of AI-based models.
The FDA's animal testing requirement will be "reduced, refined, or potentially replaced" with so-called New Approach Methodologies, or NAMs data, which include the use of AI-based models to predict a drug's behavior as well as side effects and testing on human organ-like structures made in a laboratory.