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User-Fee Sticker Shock? Industry Pursues Trimmed-Down MDUFA IV Proposal

This article was originally published in The Gray Sheet

Executive Summary

Device industry groups significantly pared down their review-process reform proposals for the next user-fee program at a meeting with FDA last month. To lower the price tag, they expunged more than a dozen ideas that have been raised by companies or the agency at prior meetings. But FDA sees a lot of important priorities missing in industry's latest five-point plan.

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