Center for Drug Evaluation and Research, U.S. Food and Drug Administration - CDER/FDA
DRUGINFO@FDA.HHS.GOV
www.fda.gov/cder/
Other Contact Information
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)
Description
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.
Print Resources
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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