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FDA and industry discuss how to get PDUFA V back on track
23 July 2010
Neena Brizmohun

The US Food and Drug Administration is pressing on with efforts to gather input on how its next prescription drug user fee programme should be framed and consider how performance failures associated with its current user fee programme, PDUFA IV, can be avoided.

The FDA was due to begin holding meetings with the regulated industry this summer to negotiate PDUFA V, which will allow the agency to continue collecting fees from pharmaceutical companies in return for meeting specific review targets...

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