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Latest From Review Pathway

ANDA Reviews Sometimes Miss GDUFA Goal Dates To Get Quicker Approval, But How Often?

Preliminary performance data suggests only a handful of applications receiving US FDA action by the end of FY 2018 actually missed their review goals.

Generic Drugs Review Pathway

US FDA Generic Approvals Break 900 Barrier In FY 2019

The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.

Generic Drugs Review Pathway

US FDA's GDUFA-Related FTEs Increase … Except In CBER

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.

Review Pathway Generic Drugs

Priority Review Vouchers Post Lower Average Approval Times Than Priority NMEs

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.

Review Pathway Regulation

Biosimilars: US FDA Ends FY 2019 With Record Number Of Approvals, One Complete Response Letter

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.


Biosimilars Review Pathway

US FDA Still Fighting Problems With Pre-ANDA Meeting Requests

More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.

Drug Review Generic Drugs

US FDA Reports Millions In Unpaid GDUFA Program Fees

The $20m in generic drug user fee receivables was 12% of the estimated total to be collected in 2018.

Generic Drugs Review Pathway

PDUFA Spending Trends: Fee Revenue Jumps As Percentage Of Funding As Staffing Grows

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.

Drug Review FDA

User Fee Delinquencies Rising At US FDA After PDUFA Redesign

Prescription drug user fee "receivables" nearly doubled in FY 2018, but the US FDA is not worried.

Drug Review FDA
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