ANDA Withdrawals Increase Faster Than Approvals
FY 2016 figure, the highest seen by US FDA under the generic drug user fee program, could be the result of older applications exiting the queue, and may be a sign of progress in dealing with the review backlog.
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US FDA receives more than 100 ANDAs during the first month of GDUFA year five, suggesting sponsors want the new 10-month review goal and cheaper user fee.
ANDA backlog is now largely cleared, FDA's Uhl notes, 'and in many cases we've actually gone above and beyond our negotiated commitments in order to really meet the stakeholder expectations.'
GDUFA funding will bring 50 additional people to the Office of Pharmaceutical Quality for generic drug review purposes.