ANDA Approvals, Submissions Decline With New Review Goal Coming
Is a rush of generic applications seeking the 10-month clock on the way?
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FDA's Office of Generic Drugs completes its best year of the GDUFA era.
GDUFA funding will bring 50 additional people to the Office of Pharmaceutical Quality for generic drug review purposes.
Since applications comprise most of the workload, they will be the focus in the next generic drug user fee cycle.