• Opinion: It's time to levy penalties for failing to report clinical trial results

    1 month ago - By STAT

    I started my first job as an attorney in the fall of 2007, days after President George W. Bush signed the Food and Drug Administration Amendments Act into law. As part of my firm's FDA group, my job was to figure out what our clients needed to do to comply with FDAAA's requirements for registering and reporting the results of their clinical trials on the government website at ClinicalTrials.gov .
    The stakes were high enough to justify my hefty hourly rate - the prospect of an initial penalty up to $10,000 for not complying with the law's requirements, followed by $10,000 a day if...
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