The Divisions of Epidemiology within CDER's Office of Surveillance and Epidemiology are located at the White Oak campus in Silver Spring, Maryland. The Divisions promote and ensure informed decision making for safe and effective use of drug and biologic products, by using epidemiologic evidence to assess the safety and effectiveness of drugs and biologics.
What we do:
• Detect, assess, and evaluate the safety and effectiveness of drugs and biologics
• Conduct drug and biologic safety and effectiveness surveillance and research using the best available epidemiologic methodologies
• Collaborate to optimize the benefit / risk balance of drugs and biologics
• Evaluate the nonmedical use and related outcomes of approved and unapproved drugs
• Use effective communications to promote the safe and effective use of drugs and biologics
• Ensure that the post-marketing requirements meet the best practices in epidemiology, and can inform regulatory decision making
• Analyze pharmaceutical sales and health care data to characterize drug utilization patterns
• Provide pharmacoepidemiologic expertise on the development and evaluation of programs and initiatives to support the Center’s policies and authorities
• Provide pharmacoepidemiologic expertise to internal and external stakeholders
