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FDA 2005 Resolutions: Faster Pre-Approval Audits, Fully Trained AP Inspectors

This article was originally published in The Silver Sheet

Executive Summary

MDUFMA IMPLEMENTATION ACTIVITIES AT FDA include new timelines for GMP pre-approval inspections, fresh efforts to get the Accredited Persons third-party inspection program off the ground, and an all-out campaign by agency officials to prevent automatic termination of user fees in October 2005. Industry groups reiterate need to stabilize fee increases. Meanwhile, FDA moves to ensure compliance by single-use device reprocessors in wake of cleaning validation review, while original equipment manufacturers urge even tougher action

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