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.
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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.
A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.