Expected Rise in Generic Applications to Lower Some User Fees

An anticipated uptick in generic drug submissions is leading the FDA to lower its fees for approval applications and supplemental filings next fiscal year.

ANDAs filed in fiscal 2017 will drop more than $5,500 to $70,480 per application, while the cost for a prior approval supplement filing will dip more than $2,700 per application to $35,240.

The agency announced these and other rate changes with the release of its GDUFA user fee schedule, which takes effect Oct. 1.