Who We Are:
The Office of Surveillance and Epidemiology (OSE) monitors and evaluates the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of the drugs. OSE maintains a system of postmarketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug development process. OSE evaluates more than 2 million adverse event reports submitted every year to FDA’s MedWatch program. OSE consists of two offices and six divisions.
What We Do:
- Postmarket safety surveillance for all marketed drug and therapeutic biologic products.
- FDA has posted a draft document titled “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff.” This best practices document is required under a provision of the 21st Century Cures Act. Comments will be accepted on this document through the related docket, as detailed in the Federal Register Notice.
- Conduct active drug safety surveillance
- Review drug safety-related epidemiologic study protocols and study reports
- Ensure that the postmarketing requirements conducted by sponsors meet the best practices in epidemiology, and can provide robust and actionable evidence to inform regulatory decision making following initial approval
- Procure, manage and analyze pharmaceutical sales and health care data to describe and characterize drug utilization levels and treatment patterns in the United States
- Work with drug companies to reduce medication errors related to confusing labels, labeling, drug packaging, and drug names that look alike or sound alike
- Provide risk management expertise on development and implementation of programs and initiatives to support the Center’s policies related to Risk Evaluation and Mitigation Strategies (REMS) authorities
- Office of Pharmacovigilance and Epidemiology
- Division of Pharmacovigilance I
- Division of Pharmacovigilance II
- Division of Epidemiology I
- Division of Epidemiology II
- Office of Medication Error Prevention and Risk Management
- Division of Medication Error Prevention and Analysis
- Division of Risk Management
Telephone: 240-402-5060; 301-796-2380
OSE Project Management Staff, WO Building 22
10903 New Hampshire Avenue, Silver Spring, MD 20993