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Web-based portal may improve quality of adverse event reports

This article was originally published in The Silver Sheet

Executive Summary

FDA and the National Institutes of Health have entered into a memorandum of understanding that aims to deliver a centralized Web-based portal for adverse event reporting that may improve report quality, lower costs and reduce delivery time. Both agencies already are working on their own revamped adverse event reporting systems. FDA has its long-term sights on a single, agency-wide electronic portal - dubbed MedWatch Plus - for collecting adverse events, consumer complaints and other information relating to all products it regulates. NIH has created the Federal Adverse Event Task Force (of which FDA is a part) to develop a portal designed so clinical trial adverse events can be reported in a single, standardized format. With the MOU, the agencies are combining efforts. "NIH and FDA aim to develop a project that will result in a Web-based method for consumers, health professionals, investigators, sponsors and other parties to electronically submit [adverse event] reports," the memorandum states

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