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 to eliminate the postmarketing requirement for expedited reporting of increased frequency of adverse events from NDAed Rx and OTC drugs and biologics published in the June 25 Federal Register. 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 or therapeutic failures. Companies still must file 15-day alert reports and follow-up reports for serious, unexpected adverse events...