FDA Generics Office To Be Managed By Relative Unknown
This article was originally published in The Pink Sheet Daily
Director Uhl’s medical leave puts bioequivalence office head John Peters in the limelight.
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Kathleen Uhl's five-month leave for cancer treatment ends as user fee negotiations move towards formal start.
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.
Picture still seems pretty grim, but FDA points to progress on several metrics.