ANDA Sponsors Given More Paperwork
But New Cover Letter Could Actually Be A Time-Saver
Executive Summary
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Growing Complex Generic Application Load May Force US FDA Staffing Changes
Complex products are slowly gaining a larger share of ANDA submission and approval totals, which could mean the FDA has to adapt its in-house expertise to compensate.
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.