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MDUFA V: FDA Looks For More User-Fee Investments; Industry Wants To Work With What’s There

US FDA commissioner Stephen Hahn argued on 27 October that his device center should consider more user-fee investments to alleviate the agency’s workload and address new innovations – but industry wants the FDA to finish hiring and work with what’s there.

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The head of the US Food and Drug Administration says his device center staff have been stretched thin meeting their Medical Device User Fee Amendments (MDUFA) obligations, and the center may need increased investments to keep up. Industry representatives, however, seemed to push back on any new investments during the first public meeting to kick off MDUFA V negotiations.

FDA commissioner Stephen Hahn started the 27 October meeting by commending his staff at the Center for Devices and Radiological Health (CDRH) for keeping up with their user-fee obligations,...

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