FDA/CDER/OND Experience With New Approach Methodologies (NAMs)
International Journal of Toxicology
Published online on November 13, 2025
Abstract
International Journal of Toxicology, Volume 45, Issue 2, Page 136-156, March/April 2026.
The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), and Office of New Drugs (OND) has continuously encouraged the submission of nonclinical tests utilizing new approach methodologies (NAMs) and sponsor engagement ...
The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), and Office of New Drugs (OND) has continuously encouraged the submission of nonclinical tests utilizing new approach methodologies (NAMs) and sponsor engagement ...