FDA moves toward animal-free drug testing

Image credit: rwgusev via Unsplash

In a landmark shift, the U.S. Food and Drug Administration (FDA) has announced a strategic plan to phase out mandatory animal testing in monoclonal antibodies and drugs. The new strategy aims to enhance drug safety and accelerate the evaluation process by adopting cutting-edge technologies such as organ-on-a-chip, AI-based computer modeling, and advanced cell-based assays. This transition is expected not only to reduce reliance on animal experiments but also to lower research and development costs, potentially leading to more affordable medications for patients.

Source

Marshall LJ, Bailey J, Cassotta, Marshall LJ, Bailey J, Cassotta M, Herrmann K, Pistollato F. Poor Translatability of Biomedical Research Using Animals - A Narrative Review. Altern Lab Anim. 2023 Mar;51(2):102-135. doi: 10.1177/02611929231157756. Epub 2023 Mar 7. PMID: 36883244.

Additional Reading

https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs

https://www.cnn.com/2025/04/10/health/fda-animal-testing-drug-approval

https://www.nature.com/articles/d41573-025-00087-x

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