FDA plans to phase out animal testing requirements

The FDA has announced its plan to phase out animal testing requirements for drug therapies, initiating a shift toward AI-based models and other “human-relevant” testing methods. A pilot program will allow select developers to employ non-animal strategies using technologies like organs-on-chips and lab-grown organoids. This move aims to enhance drug safety, reduce development costs, and address ethical concerns while potentially streamlining product reviews. The adoption of cutting-edge biosimulation software, including Certara’s products, has gained significant attention, with the FDA signaling a paradigm shift in regulatory science.

Published: Apr 10, 2025