Office of Surveillance and Epidemiology (OSE) - Divisions

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The Office of Surveillance and Epidemiology consists of three divisions:

• Division of Drug Risk Evaluation
• Division of Medication Errors and Technical Support
• Division of Surveillance, Research, and Communication Support

Division of Drug Risk Evaluation (DDRE)

DDRE staff includes safety evaluators whose primary role is to detect and assess safety signals for all marketed drug products. They work closely with medical reviewers in the Office of New Drugs so that potential safety signals are placed in the context of existing preclinical, clinical, or pharmacologic knowledge of the drugs in question.

Our epidemiologists review epidemiologic study protocols that are increasingly required of manufacturers as phase four commitments. They evaluate various postmarketing surveillance tools that may be incorporated into risk management strategies, such as patient registries and restricted distribution systems. They estimate the public health impact of safety signals by evaluating computerized databases and the published literature.

Division of Medication Error Prevention and Analysis (DMEPA) 

DMEPA primarily provides pre-marketing reviews of all proprietary names, labels and labeling in CDER in order to reduce the medication error potential of a proposed product. DMEPA also provides post-marketing review and analysis of all medication errors CDER receives. 

Division of Surveillance, Research, and Communication Support (SRCS) 

SRCS is a newly formed division that  handles data resources, risk communication, and outcomes and effectiveness research components of drug safety risk management programs. This Division oversees MedWatch, risk communication research and activities such as Medications Guides, Patient Packet Inserts, and pharmacy information surveys, and international regulatory liaison activities (such as videoconferencing) for all drug and biologic postmarketing safety issues. SRCS also manages the expansion in the use and number of safety and epidemiologic data resources.