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 has four core functions – pharmacovigilance, pharmacoepidemiology, medication error prevention and analysis, and risk management – and operates across multiple disciplines to review and assess the safety of medicines. OSE maintains a system of postmarketing surveillance and risk assessment programs to identify and evaluate adverse events and medication errors that did not appear during the drug development process. OSE evaluates more than 2 million adverse event and medication error reports submitted every year to FDA’s MedWatch program. OSE is the scientific lead for Risk Evaluation and Mitigation Strategies (REMS) review activities in CDER. OSE consists of two offices and eight divisions.
What We Do
- Perform postmarketing safety surveillance for all marketed drug and therapeutic biologic products.
- FDA has posted a final 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.
- 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 minimize medication errors, including use errors, related to drug product labels, labeling, packaging, design, and proprietary names
- Evaluate the need for a risk mitigation strategy and review proposed REMS, REMS modifications, methods to assess REMS and results of REMS assessments
Organization
The Office of Surveillance and Epidemiology consists of eight 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 I
- Division of Medication Error Prevention and Analysis II
- Division of Risk Management
- Division of Mitigation Assessment and Medication Error Surveillance
Contact Us
Telephone: 301-796-2380
OSE Project Management Staff, WO Building 22
10903 New Hampshire Avenue, Silver Spring, MD 20993
For More Information
- 2022 OSE Annual Report (PDF - 3 MB
- 2021 OSE Annual Report (PDF - 2 MB)
- 2020 OSE Annual Report (PDF - 4 MB)
- Office of Surveillance and Epidemiology (OSE) - Programs and Activities