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Regulatory Focus™ > News Articles > Quality & Compliance: A New Era: Clinical Trial Results Open to the Public

Quality & Compliance: A New Era: Clinical Trial Results Open to the Public

Posted 01 October 2008

On 27 September 2007, President George W. Bush signed the Food and Drug Administration Amendments Act (FDAAA). It established mandatory clinical trial registry and results data banks with penalties of up to $10,000 per day for failure to comply. This article provides a brief background on clinical trial registries in the US and a detailed look at what this new law requires of clinical trial sponsors.

 

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