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Adverse Events Mushroom 144% In 2007; Various Factors At Play, FDA Says

This article was originally published in The Silver Sheet

Executive Summary

ADVERSE EVENTS REPORTED TO FDA VIA ITS MDR PROGRAM continue to skyrocket, leaving agency officials to hope that a soon-to-be-mandated switch to electronic Medical Device Reporting (eMDR) will ease its workload. According to statistics from CDRH's Office of Surveillance and Biometrics, MDR reports spiked 144 percent between 2006 and 2007 - and the trend shows no signs of stopping. Currently only 12 manufacturers have joined the eMDR program, which has led FDA to reach out more aggressively to industry. “Each report that comes electronically is one less report we have to do data entry for,” says Indira Konduri, chief of OSB's Information Analysis Branch. Plus, industry experts advise firms on how to set up eMDR programs of their own.
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