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User Fee Renewal Negotiations Beginning This Week

 
• By Derrick Gingery

Talks between US FDA and industry to extend the generic drug and prescription drug user fee programs may last into 2021.

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User fee reauthorization negotiations will be virtual rather than in-person. • Source: Shutterstock

Formal negotiations between industry and the US Food and Drug Administration to reauthorize the generic drug and prescription drug user fees will begin this month, with talks for one program opening this week.

Representatives of industry and the agency will use the talks to draft improvements to the PDUFA and GDUFA programs, which generate billions in revenue for the FDA’s drug assessment and...

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