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ANDA review speeds up

This article was originally published in The Tan Sheet

Executive Summary

FDA is approving abbreviated new drug applications at a faster pace in fiscal 2004 than in FY 2003. From October 2003 through August 2004, the agency's Office of Generic Drugs approved 289 original ANDAs - five more than were cleared in all of FY 2003. The agency also tentatively approved 83 applications in the first 11 months of FY 2004, compared to 89 tentative approvals in all of FY 2003. FDA attributes the improvements to increased staff, better training and changes in procedures, which allow reviewers to verbally communicate application deficiencies to sponsors. FDA anticipates that FY 2004 also will show a surge in the total number of generic applications received, as well as a decline in the average review time for ANDAs...

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