GDUFA Accounting Challenge Already Felt By FDA, Industry
This article was originally published in The Pink Sheet Daily
Commissioner Hamburg tells GPhA that if the agency does not get an accurate count of facilities covered by the user fee program, it could under- or over-collect fees, neither of which benefits industry – or even FDA.
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Proposed and existing user fees would fund 44% of the $4.5 billion FDA FY 2013 spending plan. User fees are projected at $20 million for biosimilars and $229 million for generic drugs.
FDA will need a bit of time to develop a comprehensive database of all the facilities that produce active pharmaceutical ingredients and finished dosage forms for the U.S. market as part of the proposed generic drug user fee program.
One project will look at tablet size, odor and other characteristics that in the past have been a source of public complaints about generics.