FDA to Require Electronic Safety and Adverse Event Reports by 2010by Enterprise Labeling on Sep 4, 2009 • 5:25 pm No Comments
The US Food and Drug Administration (FDA) plans to make electronic filing of safety reports mandatory by this time next year according to this news report in Government Health IT. It is a change the FDA says will help it detect emerging safety problems sooner and respond with safety information to the public in less time.
The rule change doesn’t change the types of incidents that must be reported or the timing of the reports, according to the article. But here are some things that will change:
Electronic submission will eliminate FDA staff from having to manually enter the data into agency adverse reporting systems… The rule change would also make the United States consistent with international standards and specifications for reporting safety information.
More about this, direct from the FDA’s own news release, is here.
Also, while this move has been discussed for years, a piece in Government Computer News states that only a relatively small percentage of device reports are currently filed the new-fashioned way: Only about 15 percent of the 135,000 reports received by the devices center each year are filed electronically. The article is a good source of information on how the reporting will be done, including various technology options for large companies with many filings and small companies with far fewer reports.
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