FDA Announces Biosimilar, Prescription Drug User Fees

Law360, New York (July 31, 2012, 8:01 PM EDT) -- The U.S. Food and Drug Administration on Tuesday continued to release details on next year's user fees, announcing the fees for pharmaceutical and biosimilars applications as well as the much-ballyhooed, preapplication development fees for biosimilars.

The FDA began announcing the fee details Monday, beginning with medical devices. The FDA user fee bill signed July 9 authorized the agency to collect $718,669,000 in user fees in the 2013 fiscal year.

Drug sponsors will pay $1,958,800 in the 2013 fiscal year for a full approval application requiring clinical...
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