FDA Aligns New Pharmaceutical Inspectorate Into Six Divisions

US FDA’s structure for its new pharmaceutical inspectorate, part of the massive reorganization of the Office of Regulatory Affairs, includes four domestic divisions, a fifth handling foreign inspections and the sixth handling program functions. New staff directory could prove valuable to pharmaceutical companies learning to interact with a very different field organization.

As part of a May 15 reorganization, US FDA has established a new pharmaceutical inspectorate in its Office of Regulatory Affairs and apportioned the inspectorate's staff among four domestic regional divisions, one foreign division and one program division.

The reorganization, called program alignment, enables the agency's field organization to specialize by type of product. Investigators will no long be inspecting a food facility one week and a drug facility the next

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