The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Begins ORA Reorganization into Seven Product Sectors

May 19, 2017
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The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure, 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.

Chrissy Cochran will direct the Office of Bioresearch Monitoring Operations, a new, stand-alone program that will work with each of the FDA’s product centers to ensure subject protection in clinical studies and that non-clinical research follows Good Laboratory Practices. Cochran previously led CDER’s Division of Enforcement and Postmarketing Safety.

The Office of Biological Products Operations will be led by Ginette Michaud, previously the deputy director of CBER’s Office of Blood Research and Review. OBPO will coordinate and conduct CBER-related investigative activities and support the development of policy and guidance for biological products.

The ORA will keep its 20 existing districts and district directors will keep their responsibilities, but will also specialize in one program as division directors, the FDA said. The agency has no plans to close offices or relocate personnel. ORA’s laboratories will also specialize into either human and animal food labs or medical product, tobacco and specialty labs.

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