FDA has issued a request for information to support the NCTR Division of Bioinformatics and Biostatistics (DBB) to require Data Service electronic medical record (EMR) database system to conduct research to assess the safety surveillance of the FDA adverse event reporting systems, with the pilot study working on the FDA Adverse Events Reporting System (FAERS) (CDER) database.
“The Division of Bioinformatics and Biostatistics (DBB) requires Data Service electronic medical record (EMR) database system to conduct research to assess the safety surveillance of the FDA adverse event reporting systems, with the pilot study working on the FDA Adverse Events Reporting System (FAERS) (CDER) database. A novel data mining and data visualization method will be developed and evaluated by the large electronic medical record (EMR) system, such as VA databases. Identify patients who developed cardiovascular abnormalities (such as high blood pressure, stroke, QT prolongation, arrhythmia, etc.) after drug exposure.”
Responses are due by February 21, 2018.
