Event Date/Time: May 22, 2007 End Date/Time: May 24, 2007
Registration Date: May 22, 2007
Early Registration Date: Feb 28, 2007
Abstract Submission Date: Feb 28, 2007
Paper Submission Date: May 10, 2007
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Today, approval for NDA's is no longer assured upon completion of Phase III trials and research shows the FDA is now requiring post-marketing studies in over 70% of cases to prove a drug's long-term efficacy and safety. The situation is compounded by increasing costs – the average cost is now approaching the $4 million mark - to carry trials to phase III and beyond, difficulties with patient and clinician retention and much more.