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GDUFA III Agreement Will Constrain Fee Revenue Increases

Executive Summary

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

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US FDA Hoping To Spur More ANDA Pre-Submission Meetings During GDUFA III

The FDA believes conducting a pre-submission meeting when a complex generic application has unusual elements can increase the likelihood of a first-cycle approval.

Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

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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