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FDA’s Office of Generic Drugs

Executive Summary

Declares the week of April 23-27 as "supplement and annual report week." On Monday and Tuesday, reviewers will concentrate on annual reports filed on original ANDA applications. During the rest of the week, efforts will be focused on reviewing ANDA supplements. Since February, the office has reserved two separate weeks for the review of supplements only. These special review weeks were initiated in an effort to reduce the growing backlog of supplements and annual reports.
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PS017271

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