GDUFA III Agreement Will Constrain Fee Revenue Increases

Generic user fee program's next iteration will also offer improved mid- and post-assessment communications for sponsors to receive feedback from US FDA.

Revenue growth plant
The capacity planning adjustment's effect on other user fee programs likely lead negotiators to cap the increases it could mandate in GDUFA. • Source: Alamy

Generic drug user fee revenue increases will be constrained in the coming years, a likely response to sponsors’ concerns about the growing burden of the charges.

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