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