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Executive Summary

FDA ANDA APPROVALS DROPPED 48% IN OCTOBER to 26 versus 50 approved in October 1987. The decline follows a similar one-month reduction of 44% in September ("The Pink Sheet" Oct. 3, p. 6). The numbers indicate that investigations by Rep. Dingell's (D-Mich.) House Oversight & Investigations Subcommittee and the HHS Inspector General's office into the approval practices of FDA's Generic Drug Division are taking a toll on the division's ability to process approvals. In a speech presented at the Sept. 28 meeting of the Regulatory Affairs Professionals Society, a generic division staffer acknowledged that there was a decline in September from the monthly approval average of 56.5. However, he attributed it to problems of quality in the ANDA applications being submitted to FDA. Since the investigation began in July, there have been a total of 163 ANDA approvals through October. During the same time span last year, a total of 199 ANDA applications were approved. FDA is currently looking for an acting supervisor for its ANDA Review Branch III. Branch chief Charles Chang, one of the targets in the generics investigation, is on temporary detail in FDA's Office of Regional Operations. The supervisory spot, which will be filled by a chemist from the branch, is an interim measure position.

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