FDA announced the new PDUFA user fees for fiscal year 2011 (starts October 1, 2010). The fee for a full application containing clinical data is $1,542,000.   For a supplement or an NDA not requiring clinical data, the fee is $771,000.

A clinical study is generally Phase 2 or Phase 3, so a 505(b)(2) approved based on a  Phase 1 study is not considered a clinical study and would cost $771,000.

As always, the first NDA for a small business (less than 500 employees) is free.

Click here for a report on the FDA 2011 Budget and Appropriations.