Office of Surveillance and Epidemiology (OSE)
(Formerly the Office of Drug Safety)
- Organization within the Office
- Programs and Activities
- Regulations, Guidances and MaPPs
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.
Please feel free to send comments or questions to http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm
Adverse Event Reporting System (AERS) Medication Errors CDER 2005 Report to the Nation: Improving Public Health Through Human Drugs(PDF - 494KB) Chapter 2: Drug Safety and Quality.