Business · 15/08/1997Updated: 10/17/2026 · 1 min read

FDA Amends NDA and ANDA Regulations Following CDER Reorganization

The Food and Drug Administration (FDA) is updating its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to reflect a reorganization within the Center for Drug Evaluation and Research (CDER), aiming to enhance the accuracy of these regulations.