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Reporting of serious AEs to FDA often delayed by drug companies
Nearly 10% of adverse events are not reported to the FDA within the 15-day period drug companies have to disclose the events, according to recently published data. “Our analysis provided evidence that drug manufacturers delay reporting of serious [adverse events] to the FDA. Strikingly, [adverse events] with patient death were more likely to be delayed,” Paul Ma, PhD, Carlson School of Management, University of Minnesota, and colleagues wrote.