The U.S. government could impose more than $11.2 million in fines on companies and universities for failing to report study results on ClinicalTrials.gov, but has so far failed to do so, according to a recently launched website.
Consequently, the folks behind the new site, which is called Trials Tracker, want FDA Commissioner Scott Gottlieb to start levying the $10,000-a-day fines that are permitted under federal law and are adding up each day. Trial sponsors have 13 months from completing a study to posting summary result and side effect information, according to the FDA Amendments Act of 2007.
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And the FDA was mistaken? “Say it ain’t so, Joe!!”
Uh, make that “Ed” …..