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Office of Drug Safety


Introduction

CDER evaluates the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of the drugs. We maintain a system of postmarketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug development process. We learn about adverse events through required reporting by companies and through voluntary reports submitted to FDA’s MedWatch program, which together total more than 250,000 reports per year. Staff in the Office of Drug Safety use this information to identify drug safety concerns and recommend actions to improve product safety and protect the public health.  Activities include updating drug labeling, providing more information to the community, implementing or revising a risk management program, and, on rare occasions, reevaluating approval or marketing decisions. CDER also works with drug companies to reduce medication errors related to confusing labels, labeling, drug packaging, and drug names that look alike or sound alike.

Office of Drug Safety Organization and Responsibilities

  • Office of Drug Safety Divisions consists of three divisions.  
    • Division of Drug Risk Evaluation, 
    • Division of Medication Errors and Technical Support, and 
    • Division of Surveillance, Research, and Communication Support

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Programs and Activities

Regulations, Guidances and MaPPs

  • Regulations and Guidances This web page provides 

    • links to Federal regulations regarding postmarketing safety reporting, Medication Guides, draft and final guidance documents.  

    • Information on submitting adverse events and safety reports to FDA, 

    • Policies and procedures related to drug safety

Presentations and Publications

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Information on Using Medications Safely

Other Resources

How to Contact Us

We ask you to take time to communicate with CDER about this web site.  Please use our comments form

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FDA/Center for Drug Evaluation and Research
Last Updated: May 6, 2004
Originator: OTCOM/ODS
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