ANDA User Fee Misses Are Mostly Part Of 'Imminent Approval' Process
US FDA will miss goal dates to reach speedier generic drug application approvals, but says decisions will be case by case.
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Preliminary performance data suggests only a handful of applications receiving US FDA action by the end of FY 2018 actually missed their review goals.
The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.
Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.