Monday, July 27, 2015

Some serious drug side effects not told to FDA within 15 days

Minneapolis Star TribuneSome serious drug side effects not told to FDA within 15 daysReuters(Reuters Health) - Companies fail to report roughly one in 10 serious and unexpected medication side effects to the U.S. Food and Drug Administration (FDA) within a 15-day window specified by federal regulations to protect patient safety, a study finds.Drugmakers often lag in reporting patient "adverse events,'' Minnesota ...Minneapolis Star TribuneDrug Makers May Delay Reporting Patient Harms to FDA: StudyHealthDayReporting of serious AEs to FDA often delayed by drug companiesHealioEurekAlert (press release) -MedPage Todayall 6 news articles »

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