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Executive Summary

FDA's Division of Generic Drugs is turning over the handling of document room services to an outside contractor, Zimmerman Associates, beginning June 4. Office of Generic Drugs Acting Director Bruce Burlington informed division staff in a May 30 memorandum that the company would be entering data, identifying, processing, tracking and distributing documents. The move to an outside contractor is the latest in a series of agency efforts designed to ensure the integrity of the generic drug review process. Burlington's memo notes that access to the document room will be limited during work hours to those with an FDA identification badge and during other hours to "personnel with security zone clearance." Many of the housecleaning changes in FDA's generic review operations have been effected through a series of almost two dozen policy and procedure guidances for agency staff (see chart). Center for Drug Evaluation and Research Director Carl Peck made the agency's first formal announcement of the availability of the guides in a June 1 letter to all NDA and ANDA holders and applicants. "These guides should provide you insight into FDA's efforts to devise new policies and procedures that attempt to assure fair, and even-handed dealings with applicants," Peck said, noting that FDA will continue to issue guides.

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