(Reuters) -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 includes the use of AI-based models to predict a drug’s behavior and testing on human organ-like structures made in a laboratory.
The FDA said it will begin implementation of the new approach immediately.
The new approach would help improve drug safety, lower research and development costs and drug prices, the agency said.
“This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use,” said FDA Commissioner Martin Makary.
(Reporting by Mariam Sunny in Bengaluru; Editing by Alan Barona)
