Quality & Compliance: A New Era: Clinical Trial Results Open to the Public
Posted 01 October 2008 | By
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.