US GDUFA III Talks In Final Stages, Agreement Nearly Complete
Executive Summary
Final commitment letter preparations now under way as revenue issues are resolved.
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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.
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.
GDUFA III Talks Completed
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.