Forum Topic Regulatory Affairs
  • Conversation: Tracking FDAAA Noncompliance: AllTrials Calls on FDA to Levy Fines

    • February 20, 2018 10:18 AM GMT
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      Tracking FDAAA Noncompliance: AllTrials Calls on FDA to Levy Fines

      The international initiative AllTrials on Monday unveiled a new tracking tool to highlight clinical trial sponsors who fail to publish results as required by the FDA Amendments Act of 2007 (FDAAA).
      In an open letter to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, urging the agency to crack down on such sponsors, AllTrials founders Ben Goldacre and Síle Lane explained how FDA has the power to “levy of fines up to $10,000 a day against clinical trial sponsors who fail to publish their trial results on ClinicalTrials.gov. There are, though, trials on that register whose results are years overdue, and to date you have not issued a single fine.”
      The letter notes that relevant trials have 13 months from completion to post summary results and adverse event information, and that 17 February is 13 months since a final rule on FDAAA took effect.
      AllTrials’ FDAAA noncompliance tracking tool also went live at FDAAA.TrialsTracker.net on Monday, using data from ClinicalTrials.gov to flag sponsors that are not compliant.
      Read more: http://bit.ly/2EINoKI

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