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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.

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