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Kiss Your FDA Regional Office Goodbye: Big Changes Afoot Thanks To ORA’s Inspectional Program Alignment

This article was originally published in The Gray Sheet

Executive Summary

FDA’s five regional offices will be made whole and its 20 district offices scrambled under the Office of Regulatory Affairs' plan to align facility inspections along commodity-specific product lines, an agency official says – one of several bits and pieces of information trickling out about the coming scheme. “This is the most dramatic change that ORA has experienced, maybe in its history,” says Sean Boyd, acting deputy director in CDRH’s Office of Compliance.

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