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FDA Issues Final Rule Addressing Safety Reporting Requirements

Last modified September 28, 2010 05:58 PM - EST

Today the Food and Drug Administration (FDA) issued a final rule addressing the safety reporting requirements for investigational new drug applications (INDs). Of note, CTTI is conducting a project focused on sponsor reporting of unexpected serious adverse events (SAEs) to investigators during the conduct of a clinical trial. The ultimate objective of the project is to develop a set of recommendations for optimal reporting of SAEs to investigators that will improve human subject protection.


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