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In Brief: FDA adverse event expedited reporting

This article was originally published in The Tan Sheet

Executive Summary

FDA adverse event expedited reporting: Final rule announced to eliminate the postmarketing requirement for expedited reporting of increased frequency of adverse events with NDAed Rx and OTC drugs and biologics. Effective July 25, manufacturers no longer will be required to report within 15 working days any significant increase in the frequency of serious and expected adverse events, as well as therapeutic failures. Companies still must file 15-day alert reports and follow-up reports for serious, unexpected events. FDA proposed the rule on Oct. 28...
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