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  1. Center for Drug Evaluation and Research | CDER

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.
  • 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  

Office of Surveillance and Epidemiology (OSE) - Programs and Activities

Contact Us:

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

OSE Project Management Staff, WO Building 22

10903 New Hampshire Avenue, Silver Spring, MD 20993
 




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