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FDA, MIT Announce Drug Safety System

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At a recent conference held by Massachusetts Institute of Technology’s Center for Biomedical Innovation, the university and the Food and Drug Administration announced that they have an agreement to collaborate on the development of a real-time drug safety monitoring system.
Currently, the FDA relies entirely on reporting through its MedWatch program, which receives more than 250,000 adverse event reports from patients and health care providers about FDA-approved medications.
Since this approach is voluntary, however, it often results in the underreporting of incidents.
But the MIT-FDA initiative will go further, according to Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, in Washington.
“In addition to voluntary reports the FDA receives from patients and the health care community, the MIT model uses large health care data sets to recognize patterns that indicate unexpected efficacy or problems with safety,” Gottlieb said.
This technique is similar to that employed by public health departments and the Centers for Disease Control and Prevention in the search for incidents of infectious disease or bioterrorism.

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