About FDA

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 post-marketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug development process. OSE evaluates more than 1.5 million adverse event reports submitted every year to FDA’s MedWatch program. OSE consists of two offices and six divisions.

What We Do:

  • Detect and evaluate safety signals and assess safety-related issues for all marketed drug and therapeutic biologic products.
  • Conduct active drug safety surveillance
  • Review drug safety-related epidemiologic study protocols and study reports
  • Ensure that the post-marketing 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:

Office of Surveillance and Epidemiology

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:

Email: CDER-OSE-CONSULTS

Telephone: 240-402-5060; 301-796-2380

OSE Project Management Staff, WO Building 22

10903 New Hampshire Avenue, Silver Spring, MD 20993
 

Page Last Updated: 02/08/2018
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