FDA Publishes Generic-Drug User Fees - - BioPharm International

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FDA Publishes Generic-Drug User Fees


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FDA has published the required generic-drug user fees for fiscal year  (FY) 2014. The fees are required under the Generic Drug User Fee Amendments of 2012 (GDUFA).

FDA minimized the increase in fees due to the continued adjustment of the industry to the new requirements. Included in the FY 2014 fees is an increase over the 2013 fees. Total revenue for the first year of the program in 2013 included a one-time fee for applications pending as of October 1, 2012.  This one time fee has been removed and the remaining fees make up the total revenue, which resulted in the increase. Additional factors were used to calculate the facility fee including the number of facilities that self-identify under GDUFA.

Source: FDA.gov

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