FDA’s Office of Regulatory Affairs, which oversees the agency’s imports, inspections and enforcement policy, has established eight new offices as part of a reorganization that took effect Oct. 1. FDA created the offices to better deal with new powers received from Congress and the globalization of regulated products. The restructuring will enable ORA to operate more effectively, gather better data for analysis, create more strategic coalitions, and increase partnerships with federal, state and local officials and foreign entities, FDA said in a fact sheet. Specifically, the Office of Enforcement and the Office of Regional Operations will be replaced with three new offices: Office of Medical Products and Tobacco Operations, Office of Food and Feed Operations, and Office of Enforcement and Import Operations. The Office of Regulatory Science, Office of Operations, Office of Policy and Risk Management, Office of Communications and Quality Program Management, and Office of Partnerships have also been newly established.
[Editor’s note: Expanded coverage of the ORA make-over will be included in the Oct. 15 issue of “The Gray Sheet.”]
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