QUOTED. Aug. 24, 2018. Thomas Wicks.
Executive Summary
FDAAA Trials Tracker, an online interactive tool, has found that only 747 of a possible 1,249 trials have reported results in compliance with the Food and Drug Administration Amendments Act of 2007 (FDAAA), and that the US government could impose more than $498m in fines – but thus far has not. See what Thomas Wicks, chief strategy officer for consulting firm TrialScope, said about the Trials Tracker data here.
"That's an effort to, perhaps, cajole, nudge or shame [these sponsors] and draw attention to the lack of enforcement." –Thomas Wicks, chief strategy officer, TrialScope
- Find out more: TrialScope Anticipates FDA Will Begin Inspecting Companies For Trial-Reporting Compliance
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