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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
-
Patient
Labeling and Risk Communication.
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Drug Safety and Risk
Management (DSaRM) Advisory Committee gained full committee status on
June 1, 2002.
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MedWatch.
MedWatch, the FDA Safety Information and Adverse Event Reporting
Program, provides safety information for all FDA-regulated medical
products (drugs, biologics, medical devices, and dietary supplements)
to both healthcare professionals and the general public.
Regulations,
Guidances and MaPPs
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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Divisions and Offices
FDA/Center for Drug Evaluation and Research
Last Updated: May 6, 2004
Originator: OTCOM/ODS
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