US FDA Inspectors, Product Centers Working Closer Together Ahead Of ORA Reorg

Compliance functions will be moved to the product centers when ORA becomes the Office of Inspections and Investigations, and centers will become responsible for making the final agency decision on inspection classifications, Associate Commissioner Michael Rogers said.

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Even before the proposed reorganization of the US Food and Drug Administration’s Office of Regulatory Affairs is completed, the agency’s inspections and investigations functions already are working more closely with the individual product centers, says Michael Rogers, associate commissioner for regulatory affairs.

The most significant change as part of the reorg will involve relocating ORA’s current compliance functions to the product centers, Rogers said during a 1 May

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