Health Information Resource Database

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by the U.S. Department of Health and Human Services.]

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

Contact Information

Drug Information Branch
5600 Fishers Lane
Rockville, MD 20857

-800-FDA-1088 (Voice - Toll-free), MedWatch:(Adverse Drug Reaction)
888-INFO-FDA (Voice - Toll-free), -888-463-6332
301-796-3400 (Voice), Drug Information
301-827-4577 (FAX),

Internet Resources

www.fda.gov/cder/

DRUGINFO@FDA.HHS.GOV

Abstract

The CDER Executive Secretariat Staff (CESS), Center for Drug Evaluation and Research, responds to written consumer, health professional, professional organization, government agency, etc., inquiries covering the entire spectrum of prescription (Rx) and over-the-counter (OTC) drug issues. CESS develops Center and agency responses to drug information requests under the provision of Food and Drug Administration's (FDA's) procedural regulations and established policies. CESS prepares, maintains, and provides health and drug information/education printed materials to the public, the health care industry, Congress, foreign dignitaries, etc. Inquiries are received by fax or mail; however, all Freedom of Information requests should be sent via written correspondence to the Food and Drug Administration, Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857.

Publications

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.

Keywords

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Notes

Telephone and publication requests call Drug Information Branch (301) 827-4573

Audit

Date Entered: 3/1/1998
Date Edited: 9/10/2008
Date Revised: 2/1/2001
Health Referral Number: HR0028
Accession Number: DP91A1094

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