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)...
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Steven Niedelman, former FDA deputy associate commissioner for regulatory operations, joined Quintiles Consulting as executive VP, the firm announced Aug. 2. Upon his departure from the agency Deputy ACRAs Diana Kolaitis and David Horowitz assumed his duties (1"The Pink Sheet" June 26, 2006, In Brief). Niedelman replaces Ron Johnson, who has moved on to Quintiles subsidiary The Lewin Group, a healthcare and human services consulting firm...
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