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Counter-Terrorism Focus, Regulatory Reform Plans Will Impact CDRH

This article was originally published in The Silver Sheet

Executive Summary

NEW FDA COUNTER-TERRORISM INITIATIVES are slated to receive the bulk of any funding increase in FY 2003, leaving little monies for already cash-strapped day-to-day operations. Despite an influx of new hires, the Bush Administration’s goal of a six-fold increase in import product examinations could constrain field efforts to maintain current manufacturer inspection levels. While FDA adjusts its mission focus, consolidation plans within both HHS and FDA are expected to create more streamlined and unified operations. In the midst of these changes, Congress is set to take up a package of medical device reform measures and HHS is reviewing recommendations to ease FDA administrative burdens

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