The U.S. Food and Drug Administration (FDA) reports that it is taking action to reduce or eliminate animal testing in the development of certain categories of drugs and other medications.
In a press release, the agency announced it plans to “reduce, refine, or potentially replace” animal testing in the development and testing of monoclonal antibody therapies and other drugs. Instead, the FDA says it will favor more effective, human-relevant methods, including AI-based computational models of toxicity and cell lines, and organoid toxicity testing.
The FDA has prepared a “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” detailing some of these alternative testing methods. The agency says that the expanded use of these “new approach methodologies” (NAMs) will improve drug safety and accelerate the evaluation process, while also reducing animal experimentation.
While the FDA’s current efforts are limited to drug testing, it may be a first step in the long-term efforts to reduce or eliminate the use of animal testing in clinical trials for a broader range of healthcare-related products, including medical devices.
The FDA’s news release on its plans to phase out animal testing requirements for drugs is available at https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs.
The FDA’s Roadmap is available at https://www.fda.gov/media/186092/download?attachment.
