REGULATORY UPDATE: FDA Reorganization Receives Approval

The Food and Drug Administration recently received approval to implement a reorganization package that includes the creation of a unified Human Foods Program (HFP), adoption of a new model for its field operations and other modernization efforts. The agency plans to implement the reorganization Oct. 1.

The reorganization includes several changes of interest to the blood and biotherapies community. Notably, FDA will retitle the Office of Regulatory Affairs (ORA), the lead office for all agency field activities, to the Office of Inspections and Investigations (OII) and realign some of ORA's compliance functions to Center for Biologics Evaluation and Research (CBER)'s Office of Compliance and Biologics Quality. FDA will also establish new inspection and investigation offices to focus on inspections, investigations, and imports as its core mission.

A full list of the changes can be found in a June 3 Federal Register notice.