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.
And the FDA was mistaken? “Say it ain’t so, Joe!!”
Uh, make that “Ed” …..
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