•  Although progress has been made in providing opportunities for continuing formal interactions between industry and FDA during the drug development process, more work is needed to be done to enhance and increase access to resources at FDA, including increased informal interactions with FDA scientists and staff.

•  Some participants called for definition as to what each sector (academia, industry, the agencies) needs to do to improve and enhance the support and practice of regulatory science.

•  A next–level, precise definition of regulatory science—and the components of its practice—would spur academic medical centers to create programs in this area. This exercise would include identification of specific regulatory science competencies and definition of collaborative mechanisms established to connect academic training programs to relevant programs at NIH and FDA.

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