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Critical Path opportunities list

This article was originally published in The Gray Sheet

Executive Summary

FDA unveiled its 76-item opportunities list March 16, identifying biomarker development and clinical trial design as areas of focus for the Critical Path initiative. Device-related projects include developing surrogate outcomes for drug-eluting stent trials, establishing objective measures of the effectiveness of intraocular lenses, and creating computer models to predict effects of implanted devices prior to human testing. The list also includes nine priorities for "advancing the use of new imaging techniques" such as FDG-positron emission tomography, intravascular ultrasound and high-resolution chest computed tomography. The list has been in development since FDA announced its Critical Path initiative in March 2004 with the intent to streamline the regulatory pathway for new biomedical discoveries (1"The Gray Sheet" Jan. 9, 2006, p. 4)...
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