FDA/CDER Perspective on Use of New Approach Methodologies (NAMs) in Drug Development

Nonclinical testing of human pharmaceuticals is conducted to assess the safety of compounds to be studied in human clinical trials and for marketing of new drugs. Recent advances in science have led to the emergence of numerous NAMs for nonclinical testing that are currently being used in various aspects of drug development. A paper by scientists within the FDA Center for Drug Evaluation and Research (CDER) and the FDA National Center for Toxicological Research (Avila et al. 2020) discusses CDER’s view on the opportunities and challenges of using NAMs in drug development, especially for regulatory purposes. The paper includes examples where NAMs are currently being used in nonclinical safety assessments and where they may supplement or enhance current testing methods.