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We Support a Healthier Future - Healthy People 2020

Center for Drug Evaluation and Research, U.S. Food and Drug Administration - CDER/FDA

Organization URL(s)

druginfo@fda.hhs.gov
www.fda.gov/Drugs/default.htm

Other Contact Information

10001 New Hampshire Avenue
Hillandale Building, 4th Floor

Silver Spring, MD 20993

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

Description

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.

Online Resources

Aspirin for Reducing Your Risk of Heart Attack and Stroke: Know the Facts
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/SafeDailyUseofAspirin/ucm291433.htm
Consumer Information: Safe Use of Over-the-Counter Drug Products
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm093471.htm
Drugs@FDA
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
Generic Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm
Got a Sick Kid? Don’t Guess. Read the Label.
http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm133419.htm
Medication Errors
http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/default.htm
Medicines and You: A Guide for Older Adults
http://www.fda.gov/Drugs/ResourcesForYou/ucm163959.htm
Medicines In My Home
http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/UCM094872.pdf
MedWatch, the U.S. Food and Drug Administration (FDA) Medical Products Reporting Program
http://www.fda.gov/Safety/MedWatch/default.htm
MedWatch: Report a Serious Medical Product Problem Online
https://www.accessdata.fda.gov/scripts/medwatch/

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.