Office of Reg Affairs reorg

Executive Summary

FDA's Office of Regulatory Affairs will realign the workload of the two remaining deputy associate commissioners for regulatory affairs following the departure of Deputy for Regulatory Operations Steve Niedelman. Deputy ACRA Diana Kolaitis will "take lead responsibility for the operational aspects of ORA's work, including the achievement of our inspections and laboratory work," the agency said June 22. The director of the Office of Regional Operations will report to Kolaitis. Deputy ACRA David Horowitz will lead strategic aspects, including setting priorities and developing policies, with the director of the Office of Enforcement reporting to him. Niedelman leaves FDA at the end of June to take the role of exec VP at Quintiles Consulting (1"The Pink Sheet" June 19, 2006, In Brief)...