Overview

• The FDA confirmed it will phase out animal testing for antibody therapies, focusing on alternative methods like lab-grown human organoids.
• The updated guidelines incorporate advanced technologies such as AI-based computational models and organ-on-a-chip systems to improve drug safety evaluations.
• This initiative aims to accelerate the development of safer treatments while reducing research and development costs.
• The FDA will rely on real-world safety data from international studies to validate alternative testing methods for drug approval.
• This decision builds on the FDA Modernization Act 2.0, reflecting a broader shift toward ethical and scientifically advanced drug evaluation practices.