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GDUFA III: How Much Of A Fee Increase Can Industry Stomach?

 
• By Derrick Gingery

Amid questions about generic industry market dynamics, the user fee renewal could focus on limiting increases in US FDA collections.

User Fee Reauthorization Preview 2020
Worries about the generic industry's health may weigh on user fee renewal talks. • Source: Pink Sheet illustration

Generic drug user fee increases may be hard to come by in the next round of program reauthorization talks amid questions about industry and the generic market health, as well as US Food and Drug Administration performance going forward.

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More from Biosimilars & Generics

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