1. Pink Sheet

Generic User Fee Talks Reach 'Final Wording' But Still Not Done

 
• By Derrick Gingery

FDA and industry say they have reached tentative agreement, but finance subgroup says more discussion needed.

FDA and industry appear close to finishing generic drug user fee program renewal negotiations, but have yet to agree on fee structure adjustments.

Agency and industry negotiators said they had "tentatively agreed on the final wording of the GDUFA II commitment letter" after a July 25 session, according to meeting minutes.

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