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FDA new drug user fees proposed to offset budget cuts in President's FY 1999 request.

This article was originally published in The Tan Sheet

Executive Summary

FDA FY 1999 BUDGET WOULD INCLUDE $19 MIL. IN NEW DRUG USER FEES to offset a proposed cut of $21 mil. in the budget authority for human drugs under President Clinton's budget request for fiscal 1999 released Feb. 2. The new fees for the operating year beginning Oct. 1 would cover generic drugs and postmarketing surveillance. FDA's core review functions are protected by the Prescription Drug User Fee Act, which provides $132.3 mil. in user fees during FY 1999 and stipulates that the base appropriations may not be cut. OTC drugs approved under NDAs are subject to FDA user fees.
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