MAY 21, 2009 5:04am ET

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FDA Easing Adverse Event Reporting


The Food and Drug Administration is developing a new Web portal to improve its adverse event reporting systems for all products it regulates.

The new MedWatch\Plus\Portal will enhance the existing MedWatch data collection system and enhance integration with various FDA adverse event reporting systems.

The portal will provide one central point of entry for reporting safety concerns by manufacturers, providers, consumers and others.

The portal will include "a user-friendly data collection tool, the 'Rational Questionnaire,' which will make it easy for anyone to report a safety problem," according to a notice published May 20 in the Federal Register. "The Rational Questionnaire will ask users simple questions to help guide them to determine what information they should provide. Anyone will be able to use the questionnaire to submit adverse event, product problem/consumer complaint, and medication use error reports to the FDA."

For the complete notice, click here.

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