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FDA Eyes The Future: 2010 Workshop To Address Integration Of "New Science"

This article was originally published in The Gray Sheet

Executive Summary

FDA's device center will hold a public workshop in February to help formulate a strategy for integrating "new science" into its regulatory decisions

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CDRH Task Force Stirs Debate About FDA's Comparative-Effectiveness Role

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CDRH Task Force Stirs Debate About FDA's Comparative-Effectiveness Role

FDA stakeholders debated Feb. 9 whether it is appropriate for the agency to compare the effectiveness of new devices to the status quo as part of its pre-market reviews

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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