2012 PDUFA User Fees
The 2012 PDUFA User Fees have been announced in the Federal Register. In summary, the fees are:
Applications:
Establishment fee: $520,100
Product: $98,970
For those doing the math, the cost of the full application fee has gone up almost 19% from this past year (2011 fee: $1,542,000).
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Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.