2012 PDUFA User Fees

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).