The US Food and Drug Administration (FDA) on Thursday revised draft guidance from 2017 on the generic drug user fee program (GDUFA II) to explain how the new fee structure works and what types of fees will be assessed.
GDUFA II, which extended FDA’s authority to collect user fees from FY 2018 through FY 2022, eliminated prior approval supplement fees and added GDUFA program fees. In addition, the new program clarifies that facilities that manufacture both active pharmaceutical ingredient (APIs) and finished dosage forms (FDFs) will only incur FDF fees.
“A facility no longer incurs a fee if it is only referenced in pending generic drug submissions because the facility fee obligation now applies only to facilities referenced in approved generic drug submissions,” FDA explains, also noting how contract manufacturing organizations pay one-third the amount of the facility fee incurred by FDF facilities.
The 29-page draft further discusses backlog fees, drug master file fees, abbreviated new drug application filing fees, facility fees and generic drug applicant program fees. The agency also explains what happens if companies fail to pay certain fees, how to pay the fees and how to appeal an FDA decision that fully or partially denies a request for a refund or reduction of fees.
As far as changes between this draft and the one from 2017, FDA says: “Clarifying language was added to the revised draft guidance based on the public comments submitted for the draft guidance.”
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