Business · 12/10/2007

FDA Announces Prescription Drug User Fee Rates for Fiscal Year 2008

The US Food and Drug Administration (FDA) has set the rates for prescription drug user fees for the fiscal year 2008, which will be effective on October 1, 2007, and will remain in place until the end of the fiscal year. The fee rates include $1,178,000 for applications requiring clinical data, $589,000 for applications not requiring clinical data or supplements, $392,700 for establishment fees, and $65,030 for product fees.