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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FDA’s ‘Imminent Action’ Policy Likely Not Best Path For ANDAs To Address Late Brand Label Changes
The policy allowing the FDA to work past a goal date could be used to deal with the generic delaying tactic, but an industry expert said other avenues to quickly dispatch labeling issues may be more appropriate.
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.