FDA Restructures Office of Regulatory Affairs

May 15, 2017

The U.S. Food and Drug Administration (FDA) released details on the structure of its newly realigned Office of Regulatory Affairs (ORA). The move, part of FDA's program alignment, is aimed at more closely aligning the agency's inspection efforts with the various products it regulates.

"Specializing by FDA-regulated product type more closely mirrors the organizational model of FDA's centers and the industries we regulate," FDA says.

Under the agency's previous regional model, ORA was organized across five regional offices and 20 district offices. Now, the agency is replacing the five regional offices—Central, Pacific, Northeast, Southeast and Southwest—with seven product or operations aligned offices.

According to FDA, the field laboratories will also be aligned by product area, focusing on food, medical products and tobacco, or both.

FDA spokesperson Lyndsay Meyer told RAPS that the agency will not be closing any offices, and that none of ORA's staff would lose their jobs or be asked to relocate as a result of the restructuring.

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