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

This contract pertains to the continuation of a program focused on active surveillance of adverse drug events (ADEs) to support regulatory decision-making and abuse prevention efforts by the FDA. It enables the agency to collect post-marketing data on prescription and over-the-counter drug abuse from individuals entering or undergoing assessment for substance abuse treatment. The objective is to enhance the granularity of surveillance data, allowing for more detailed and stratified analysis of drug abuse patterns across all CDER medical products. Funding for this contract is divided between the Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Amendments (GDUFA), reflecting its broad scope. The increased funding facilitates improved data collection and analysis capabilities, ensuring continued program support and enabling more informed regulatory actions. The contract is managed by the FDA’s Center for Drug Evaluation and Research, with key points of contact identified for program coordination and acquisition oversight.