FDA encourages Transition to Non-Animal Testing Methods for Monoclonal Antibodies

The FDA is shifting its approach to drug development by promoting New Approach Methodologies (NAMs), such as AI-based computational models and human cell-based lab tests like organoids and organ-on-a-chip systems. These methods aim to enhance the accuracy of predicting human drug responses, reducing reliance on animal models. The policy, effective immediately, encourages the inclusion of NAMs data in investigational new drug (IND) applications and will also incorporate real-world safety data from countries with comparable regulatory standards for drug efficacy assessments.

FDA Commissioner Dr. Martin A. Makary emphasized that these innovations could accelerate the development of safer, more cost-effective treatments while aligning with ethical considerations. Key components of the initiative include AI-powered drug behavior simulations, human tissue-based lab models for drug interactions, and regulatory incentives to streamline reviews for applications with robust non-animal testing data. This approach is part of the FDA Modernization Act 2.0, which removed the mandatory animal testing requirement for drug development.

13-05-2025