FDA to Ease Adverse Event Reporting

HDM Breaking News, October 23, 2008

The Food and Drug Administration is seeking comment on a new Web portal under development that would provide a one-stop place to file reports of adverse events associated with the use of regulated products.

FDA has launched the development and implementation of the MedWatch/Plus/Portal, an enhanced, Web-based version of its existing MedWatch collection system. "The agency believes that one central point-of-entry will better enable persons to submit their information," the FDA said in a notice published Oct. 23 in the Federal Register. "In addition, mandatory reporters will be able to use the Internet to access the MedWatch/Plus/Portal to report safety concerns about dietary supplements, nonprescription drugs, and human and animal food, thus fulfilling the mandatory reporting requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, and the Food and Drug Administration Amendments Act of 2007."

The portal will include a data collection tool called the "Rationale Questionnaire" to ease the reporting of a safety problem, according to the FDA. The questionnaire will ask simple questions to help users determine what information they should provide.

Anyone--including consumers, clinicians, researchers and medical device makers--will be able to report adverse events, medical errors, product complaints and other adverse reports. "The system will compile the user's responses into a standardized report that would be routed to the appropriate FDA organizational components for review and analysis," according to the notice.

More information is available at gpoaccess.gov/fr/index.html.

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