1. Pink Sheet

PDUFA Acronym War Begins: Could Reauthorization Be Called Patient-UFA?

 
• By Michael Cipriano

For first time ever, the administration that negotiated a user fee agreement won’t be shepherding its reauthorization through Congress.

Capitol House

The surprise election of Donald Trump as president has disrupted planning for industry and patient advocates alike. Companies mostly seem to think that’s a good thing, but one area where they are hoping for strong continuity is in the user fee program.

Industry and advocates outlined the topics at stake for the upcoming renewal of the Prescription Drug User Fee Act (PDUFA)...

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