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...
But so far, even broadening the eligibility beyond the GDUFA III commitment has not prompted any generic drug sponsors to request a meeting with FDA staff about issues created by updated or new product-specific guidances. The size of the request package could be one factor.
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.