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.
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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.
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.