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Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Contact Information

Drug Information Branch
10001 New Hampshire Avenue
Hillandale Building, 4th Floor

Silver Spring, MD 20993

1-800-FDA-1088 (Voice - Toll-free)
1-888-463-6332 (Voice - Toll-free)
301-796-3400 (Voice)

Internet Resources


The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers medicines and other drugs, including fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens.


CESS publications include labeling for FDA approved prescription drugs, CESS Fact Sheets, CESS information packets, FDA Consumer magazine reprints, drug information brochures, FDA Backgrounders, FDA Talk Papers, and FDA Medical Bulletin. CESS regulatory publications include guidelines, information packets, and Federal Register notices relative to the drug approval process. Information and guidance to order other regulatory manuals, directories, or drug evaluation reports are also available.


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Date Entered: 3/1/1998
Date Edited: 12/20/2012
Date Revised: 2/1/2001
Health Referral Number: HR0028
Accession Number: DP91A1094

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