PDUFA User Fees Fall for Fiscal 2017

The FDA is lowering the cost of prescription drug submissions starting next fiscal year due to an anticipated rise in filings.

When fiscal 2017 begins on Oct. 1, the cost of filing an NDA with clinical data will tumble more than $336,000 to around $2.04 million per application, the agency revealed with the announcement of its new rates under PDUFA.

Similarly, the cost for two more submissions — NDAs without clinical data and supplemental submissions — will dip more than $168,000 per application to about $1.02 million per filing.