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TrialScope Anticipates FDA Will Begin Inspecting Companies For Trial-Reporting Compliance

Executive Summary

US FDA will soon ramp-up enforcement of the clinical trial transparency provisions of Title VIII of the Food and Drug Administration Amendments Act of 2007, according to TrialScope Chief Strategy Officer Thomas Wicks. Those that fall foul of these new requirements will face penalties  and it looks like SMEs will be hardest hit.

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