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User fee audit

This article was originally published in The Gray Sheet

Executive Summary

FDA holds conference call with Health Industry Manufacturers Association reps Jan. 24 to discuss results of a HIMA-commissioned Price Waterhouse audit of the agency's user fee budget model. While the report affirms the validity of the agency's basic model, FDAers say, it also questions some of FDA's assumptions used in determining revenues required by the program. As a result, Price Waterhouse reportedly arrived at lower user fee program cost estimates than FDA's current figures



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