CDER Office of Surveillance and Epidemiology Also referred to as: CDER Office of Surveillance and Epidemiology
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
Organization
The Office of Surveillance and Epidemiology consists of Six divisions:
- 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
Contact Us
Telephone: 240-402-5060; 301-796-2380
OSE Project Management Staff, WO Building 22
10903 New Hampshire Avenue, Silver Spring, MD 20993
For More Information
- 2020 OSE Annual Report (PDF - 4.3 MB)
- Office of Surveillance and Epidemiology (OSE) - Programs and Activities