FDA: User fee for review of DTC ads for drugs is mothballed

January 18, 2008

FDA's user fee program for review of DTC TV ads for Rx drug, biologic products will not be implemented

The Food & Drug Administration has issued a notice in the Jan. 16 Federal Register informing companies that the direct-to-consumer (DTC) television advertisement user fee program will not commence because the necessary user fees for the program were not "provided in advance in appropriations acts" as required by the FDA Amendments Act of 2007 (FDAAA). So the previously issued notice establishing user fee rates for the program for fiscal year (FY) 2008 is being withdrawn. For more information, e- maildtcp@fda.hhs.gov.

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