GDUFA III Agreement Will Constrain Fee Revenue Increases

 
• By Derrick Gingery

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

More from Generics

More from Biosimilars & Generics