Welcome from the Office of
Surveillance and Epidemiology
Description
Mission
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
Surveillance and Epidemiology 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
- 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.
How to Contact Us
Please feel free to send comments or questions
to http://www.fda.gov/cder/comment.htm.
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