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Latest From Review Pathway
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.
Employees performing generic drug user fee program and related work increased nearly 68% between FY 2014 and FY 2018; Costs, as well as dependence on fees to pay for them, also increased during the period.
US FDA’s priority review voucher program delivers for most sponsors, a Pink Sheet analysis finds; PRVs reliably produce faster approval than priority-reviewed new drugs overall.
Agency approved 11 biosimilars from six sponsors with only one publicly disclosed complete response letter (Tanvex’s filgrastim). Pink Sheet infographic shows 351(k) application submission, approval and CRL rates over the life of the user fee program.
More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.
The $20m in generic drug user fee receivables was 12% of the estimated total to be collected in 2018.
FY 2018 is first year that US FDA's device center got PDUFA funding for staffers; our infographic shows how CDER is getting an increasing proportion of user fee staff even as other sections of the agency have seen growth over the last five years.
Prescription drug user fee "receivables" nearly doubled in FY 2018, but the US FDA is not worried.
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