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FDA stakeholders meeting Sept. 8

This article was originally published in The Tan Sheet

Executive Summary

Will address a wide variety of topics as they pertain to the FDA Modernization Act. Issues will include how FDA can improve its explanation of agency product review processes; what can be done to increase the clarity of information available from FDA on newly approved products; how the agency can sustain an effective postmarketing surveillance system; and what can be done by the agency to create a proper infrastructure so as to ensure scientific-based decision-making. Additional topics are how FDA can meet its obligations for a non-user fee review; how product review/approval backlogs can be eliminated, as well as other obligations that should be included in FDA's mandate. The meeting will be held at the Bethesda, Md. Hyatt Inn, beginning at 1 p.m...
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