Overview

• The FDA has announced it will phase out animal testing requirements for monoclonal antibody therapies and other drugs, replacing them with human-relevant methods.
• New approaches include AI-based computational models, lab-grown human organoids, and organ-on-a-chip systems to test drug safety and efficacy.
• The initiative aims to improve drug safety, speed up development timelines, and lower research and development costs, ultimately reducing drug prices.
• A roadmap has been launched to implement these changes, including pilot programs and updated guidelines to encourage adoption of non-animal testing methods.
• Animal rights groups and some experts have praised the move as a significant ethical and scientific advancement in modern drug evaluation.