Center for Drug Evaluation and Research

From WikiMD's Food, Medicine & Wellness Encyclopedia

The Center for Drug Evaluation and Research (CDER, pronounced see'-der) is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. The center reviews applications for brand name, generic, and over the counter pharmaceuticals, manages US current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a medical prescription, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market.

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Contributors: Prab R. Tumpati, MD