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Hamburg Seeks To Rebuild FDA After Years Of Insufficient Resources

This article was originally published in The Gray Sheet

Executive Summary

FDA needs more funding to make up for years of neglect, Commissioner Margaret Hamburg said Feb. 8 at the AcademyHealth National Health Policy in Washington, D.C

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Foreign Manufacturing Cost-Savings Might Be Offset By Regulatory Due Diligence, FDA's Woodcock Cautions

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Obama Budget Request Would Fund National Device Registry At FDA

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Regulatory News In Brief

PREDICT at borders: FDA hopes to have its new border inspection tool, Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting, up and running nationwide by spring, Commissioner Margaret Hamburg said Feb. 4. The IT system considers various characteristics to pinpoint shipments in need of more comprehensive inspection and items that are less risky. It has been piloted for food inspections since 2007 and more recently for device and drug shipments (1"The Gray Sheet" Oct. 19, 2009)

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