FDA Begins ORA Reorganization into Seven Product Sectors

The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure Monday, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers.

The change follows nearly four years of planning. The previous regional configuration will be replaced with separate divisions covering pharmaceuticals; biologics; bioresearch monitoring; medical devices and radiological health; human and animal food; tobacco; and import operations.

The agency has published a series of fact sheets explaining what each product office does. For example, the Office of Pharmaceutical Quality Operations contains four divisions spanning several of the agency’s previous districts — OPQO staff will conduct drug product investigations and manage compliance activities across the ORA’s 20 district offices.

The OPQO will be led by Alonza Cruse, who previously served as acting director of the ORA’s Office of Medical Products & Tobacco Operations from 2013 to 2015.