Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research (CDER) is the Center within the U.S. Food and Drug Administration that regulates prescription, over-the-counter, and generic drugs. This responsibility includes products that many consumers usually do not associate as drugs, such as fluoride toothpaste, dandruff shampoos, and sunscreens. Although most biologics are regulated by the Center for Biologics Evaluation and Research (CBER), monoclonal antibodies, therapeutic proteins, and immunomodulators fall under CDER’s regulatory oversight.
U.S. Food and Drug Administration (FDA): Frequently Asked Questions about CDER
U.S. Food and Drug Administration (FDA): Transfer of Therapeutic Products to the Center for Drug Evaluation and Research (CDER)
NCATS Toolkit for Patient-Focused Therapy Development: Discovery of Therapeutic Approach