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.
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Additions could help streamline generic development, Center for Drug Evaluation and Research Director Patrizia Cavazzoni says.
A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.
Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.