GDUFA III: Convening Enhanced Mid-Cycle Meeting Will Cost Sponsors
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.
You may also be interested in...
Optional checklists will help ensure submissions have all the required information.
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.