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In Brief: Rx-to-OTC switch application fee revenues

This article was originally published in The Tan Sheet

Executive Summary

Rx-to-OTC switch application fee revenues: Expected to total $5 mil. under the President's proposed FY 1998 budget, FDA says in a Feb. 6 budget summary document. The Administration's fiscal 1998 budget proposal also calls for new fees for "medical device reviews, animal drug approvals, import inspections, food additive petition reviews, generic/over-the-counter applications and fees for postmarket surveillance of products." Nonprescription Drug Manufacturers Association President James Cope said in November that the association was "willing" to consider user fees for OTC drug monograph activities as it had during the 1991 negotiations for PDUFA...
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