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CDER/ORA improved communication pilot

Executive Summary

FDA's Office of Generic Drugs, Office of Compliance and Office of Regulatory affairs have successfully completed a pilot effort to improve communications between reviewers and field staff, an area that received criticism during the generic drug investigations. In the pilot effort, an ANDA reviewer accompanied an FDA field investigator during a preapproval inspection for Sterling's lidocaine 2%, and addressed problems in the application, which was approved on Feb. 26, on site. FDA said that results of the program were "positive" and the agency is assessing "the costs and benefits of applying such an approach on a broader basis".
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PS022246

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