Zdrowie i gospodarka · 01/08/2012

FDA Announces Prescription Drug User Fee Rates for Fiscal Year 2013

The Food and Drug Administration (FDA) has announced the prescription drug user fee rates for fiscal year 2013, which are set by the Prescription Drug User Fee Amendments of 2012 (PDUFA V). The rates include $1,958,800 for applications requiring clinical data, $979,400 for applications not requiring clinical data, and $526,500 for establishment fees.