Resource Gap Remains Between Industry And FDA User-Fee Proposals
This article was originally published in The Gray Sheet
Executive Summary
FDA wants more user-fee support to shore up its review staff and management structure, and to leverage real-world data, than industry groups are currently willing to spend, recent user-fee negotiation meeting minutes show. Companies, meanwhile, continue to ask for new performance goals for pre-submissions, de novo reviews and CLIA waivers.
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