CDer

CDER stands for the Center for Drug Evaluation and Research, a subsidiary center of the U.S. Food and Drug Administration (FDA). It administers the regulation of prescription and over-the-counter human drugs in the United States, with the aim of ensuring that medicines are safe, effective, and properly labeled for their intended use. The center reviews new drug applications (NDAs) and applications for generic drugs (ANDAs) and oversees the ongoing safety monitoring of approved products. CDER also develops and enforces quality and labeling standards, including information about indications, dosing, warnings, and adverse events.

In its regulatory role, CDER assesses the benefits and risks of products and may require risk management strategies or post-market studies. It administers fast-track and other expedited review programs for eligible therapies and works to approve beneficial medications promptly while maintaining rigorous evidence standards. The center coordinates with other FDA components, external sponsors, and public stakeholders to develop guidance documents and scientific standards for drug development, testing, manufacturing, and surveillance.

Post-market surveillance is a key function; CDER collects and analyzes safety data from adverse event reports and other sources, communicating safety information through drug safety communications and labeling changes. It also oversees compliance and enforcement actions for products that fail to meet regulatory requirements. Overall, CDER aims to protect public health by ensuring that legally marketed drugs are safe, effective, and properly described.