FDA Unveils User Fee Hikes To Fund Review Of Drugs, Devices

Law360, New York (August 2, 2013, 5:32 PM EDT) -- The U.S. Food and Drug Administration on Thursday unveiled its annual set of user fees paid by drugmakers and medical device companies to fund review of their products, and as usual, rates are set to climb, in some cases dramatically.

Fees for full applications that cover new drugs and require clinical data will rise more than 10 percent to almost $2.2 million from slightly less than $2 million. For new drug applications not involving clinical data, or for supplemental applications that do require clinical data, fees...
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