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FDA’s ORA reorganization to be ‘stood up’ on May 15, but take years to be fully operational

The long-awaited Office of Regulatory Affairs (ORA) reorganization that will make FDA inspectors more specialized is just weeks away from being “officially stood up,” but it will take several years to be fully operational, said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, during a March 28 hearing on Capitol Hill.

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