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Adverse Events Reporting System Needs Immediate Upgrade – FDA Consultant

This article was originally published in The Tan Sheet

Executive Summary

FDA should resume an abandoned plan for software acquisition and "immediately" begin the process of upgrading Center for Drug Evaluation and Research's Adverse Events Reporting System, a consultant hired by the agency recommends in a report that is highly critical of the center's efforts to create a second-generation AERS

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FDA has at least 16 projects under way to improve its information technology systems and infrastructure, but no comprehensive IT strategic plan to coordinate and manage the efforts, according to the Government Accountability Office

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FDA has at least 16 projects under way to improve its information technology systems and infrastructure, but no comprehensive IT strategic plan to coordinate and manage the efforts, according to the Government Accountability Office

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