GDUFA Guidance Offers Peek At Generic Drug User Fee Levels

A new guidance includes preliminary estimates of backlog, application and drug master file fees under the new generic drug user fee program. However, the agency must wait for Congress to pass an FY 2013 appropriations bill or continuing resolution with language allowing it to collect the new revenue.

FDA has estimated nearly all of the generic drug user fees that sponsors and manufacturers should expect to pay when the program launches in October, but admits that some of the calculations could be complicated.

Most of the actual fee amounts are targeted for release by Oct. 31, although estimates included in a new Q&A...