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2012 PDUFA User Fees

Published On: August 7, 2011

The 2012 PDUFA User Fees have been announced in the Federal Register.  In summary, the fees are:

Applications:

  • Full – requiring clinical data (e.g., Phase 2 or 3):  $1,841,500
  • Not requiring clinical data                                 :         920,750
  • Supplements requiring clinical data                  :         920,750

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).