FDA to award sole source to access VA EHR surveillance databases

The U. S. Food and Drug Administration (FDA) intends to award a sole source firm-fixed price purchase order to Biomedical Research Foundation, 4300 W. 7th St., Little Rock, AR, 72205 to access the U.S. Department of Veterans Affairs (VA) Electronic Health Record (EHR) surveillance databases.

The FDA will issue only one RFQ to the Biomedical Research Foundation. However, all responsible sources that have current and documented access to the U.S. Department of Veterans Affairs (VA) Electronic Medical Record (EMR) System and capable of conducting research to assess the disparities on drug-host interaction of drug-induced liver injury (DILI) reported in VA EMR System may submit a capability statement…

The Division of Bioinformatics and Biostatistics (DBB) requires use of the EMR database developed by the U.S. Department of Veterans Affairs (VA) Informatics and Computing Infrastructure (VINCI) to conduct research to assess the safety and surveillance of regulated products within the FDA adverse event reporting systems (FAERS). This project will use the FAERS database maintained by the Center for Drug Evaluation and Research (CDER) to develop a novel data mining and data visualization method and evaluated by using an EMR system for drug induced cardiovascular abnormalities (i.e., high blood pressure, stroke, QT prolongation, and arrhythmia) after drug exposure.

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