Friday, December 08, 2006

IT changes on the way for FDA's Rx safety reporting system

IT changes on the way for FDA's Rx safety reporting system

Data mining and improving the FDA's Web portal so that anyone can report adverse drug events are some of the changes that are coming for the FDA's drug safety system. The FDA will also produce regular reports about the adverse events being reported. The information will be available to the public. Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, detailed the changes in a speech last month, reports Government Health IT. There will also be EMR-compatible software for healthcare practitioners to download and use to report drug events. According to Government Health IT, there is no set timetable for implementing the changes. However, Gottlieb said over the summer that the FDA plans to have in place within two years a single electronic reporting system for adverse drug and device events.

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