Overview
The Office of Compliance (OC), in FDA's Center for Drug Evaluation and Research (CDER), identifies, assesses and prioritizes legal violations based upon their potential risk to public health. OC uses qualitative and quantitative data analysis and strategic problem solving to target compliance actions and develop innovative compliance strategies to reduce public health risks associated with potentially dangerous products. The following surveillance tools are used by OC to protect public health:
- Drug registration and listing
- Adverse Drug Experience (ADE) Reporting Program
- Drug quality reporting
- Risk evaluation and mitigation (REMS) strategies
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