Development of a statistical modeling and surveillance framework for postmarket drug prescribing and risk-mitigation behavior
The FDA is authorized to approve important, high risk drugs by requiring Risk Evaluation and Mitigation Strategies (REMS) to manage risk. The most restrictive policies in a REMS are Elements to Assure Safe Use. Currently, monitoring involves pharmaceutical companies providing annual REMS assessments to the FDA. This level of monitoring is limited in that does not involve a rigorous statistical analysis framework and does not involve independent data sources (e.g. prescription drug claims). This dissertation aims to provide methods for the FDA and other public health agencies to analyze drug ...
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