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GDUFA II Negotiations: Let the Saber-Rattling Begin

This article was originally published in RPM Report

Executive Summary

The reauthorization of the Generic Drug User Fee Act isn’t going to be as straightforward as the PDUFA process has been for the past two decades. Instead, expect a replay of the first medical device fee renegotiation – with plenty of threats from industry to walk away from the program altogether, likely intended to end up with the best possible deal.


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