RSAR: Post-marketing RX Drug Abuse Surveill Data Denver Health Data Source

This contract supports the Food and Drug Administration in conducting active surveillance of adverse drug events to inform regulatory actions and abuse prevention programs. The primary objective is to obtain post-marketing surveillance data for both prescription and over-the-counter drugs, specifically focusing on data generated from individuals entering or being assessed for substance abuse treatment. This effort is part of an option year four service agreement intended to ensure program continuity. Funding for this initiative is split between PDUFA and GDUFA and covers all CDER medical products. A proposed increase in funding is intended to enhance the granularity of the data, allowing for more detailed stratified results. The project is managed by the FDA and utilizes Denver Health as a data source.