Scale of Fees
FDA calculates the fees for the following year based on the expected work (applications etc.) and the amount it wants to raise from the fees. For 2008 the application fees are :
- $1,178,000 per full application requiring clinical data,
- $589,000 per application not requiring clinical data or per supplement requiring clinical data.
There are also establishment fees and product fees.
Read more about this topic: Prescription Drug User Fee Act
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