Advancing Regulatory Adoption of New Approach Methodologies.

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has a long history advancing new approach methodologies (NAMs). In collaboration with external organizations and other regulatory agencies, FDA supports continued development of NAMs for regulatory use. Within CDER, qualification programs and interdisciplinary review teams provide opportunities for increased regulatory impact of NAMs. CDER also continues to provide regulatory input to NAMs developers and end users to advance regulatory acceptance of NAMs.