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Adverse Event Initiatives Aim For Better Data, Easier Reporting

This article was originally published in The Silver Sheet

Executive Summary

DEVICE ADVERSE EVENT REPORTING is gradually becoming less burdensome and more standardized as the result of initiatives at FDA and internationally. The MedSun program for a small subset of hospitals is well on its way toward eventually replacing universal user reporting of adverse events, with FDA officials saying the system is providing high quality information that can help manufacturers better understand problems that health care practitioners encounter with their products. Meanwhile, the Global Harmonization Task Force anticipates greater ease for industry in reporting adverse events to international regulatory bodies under its comprehensive reporting guidance, now nearly complete. National regulatory authorities, in turn, will find their job of sharing event data with one another simpler under a new coding system developed by ISO Technical Committee 210





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