FDA’s manufacturing supplement review performance
This article was originally published in The Gold Sheet
With two thirds of the year's deadlines already past, FDA had fallen behind its goal for review of prior approval manufacturing supplements in fiscal year 2008, but there was still time to catch up, according to the FY 2008 Prescription Drug User Fee Act Performance Report the agency released last month. The goal was to act on 90 percent within four months; the performance was 88 percent. For manufacturing supplements not requiring prior approval, FDA was ahead of the game: the goal was to act on 90 percent within six months; the performance was 97 percent. In all, FDA received 2,517 requests for manufacturing supplements that year, close to the 2,588 yearly average of the previous five years
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