FDA establishes PDUFA rates

WASHINGTON The Food and Drug Administration has established user fee rates for fiscal 2008 under the Prescription Drug User Fee Act, which will lasts until Sept. 30, 2008.

The revenue amount for fiscal 2008 is $459,412,000, including application, establishment and product fees which will provide one-third of the total revenue. The FDA also estimates that 35 establishment fee waivers will be made for 2008, with 10 waivers coming from a new orphan drug exemption in the FDA Amendments Act, which reauthorized the PDUFA.

The fees for each category are available at the FDA’s website.