"Critical Path Initiative - An Opportunity for Partnership in Statistics"
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*George YH Chi, J&JPRD 

Keywords: Critical Path Initiative, Critical Path Opportunities, partnership

The essential goal of the March 2004 FDA Critical Path Initiative is to modernize the current product development process so that a potential drug, biologic, or medical device in the discovery phase can be brought to the end stage as a medical product that is safe and effective in an efficient manner that results in low failure rate. To achieve this objective, FDA has subsequently identified in March 2006 over seventy Critical Path Opportunities, areas of product development process that need urgent attention in this modernizing effort. The purpose of this talk is to review some of the current activities on the statistical front, and point out opportunities for further enhancement of the current efforts.