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Divisions
Office of
Surveillance and Epidemiology Divisions 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 Errors and Technical Support
(DMETS)
DMETS 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. DMETS 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. |
