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Fast Track: FDA User Fees: Do Faster Review Times Justify the Financial Burden?

The Food and Drug Administration (FDA) recently began requiring applicants to pay significant user fees when filing applications in connection with new medical devices and biologics. Such user fees have long been required for drug-related applications, and now also are required for applications related to devices and biologics. In theory, user fees enable FDA to speed up application review time, b......

Full article >>> ken innovative start-up companies. Moreover, user fees have created a two-tiered review system, where FDA reviews fee-based applications preferentially. Although not every application requires a user fee (and smaller businesses should become familiar with these exceptions), FDA reviews fee-based applications first, before moving to applications that are exempt. Thus, user fees may not only be putt......

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'"/> By Morris Waxler, Ph.D. and Gabriel S. Gross 04/22/03

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