Fee standard for generic drug use in the United States in fy2013
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Last Update: 2012-10-26
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Source: Internet
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Author: User
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Source: on October 26, 2012, according to the generic drug use fee Act (gdufa), FDA needs to determine the rate of generic drug use fee every year, and issue the standard of generic drug use fee for this fiscal year 60 days before the beginning of the next fiscal year FDA expects to raise an average of US $299 million annually through the project in the next five years, of which 24% is from anda and PAS declaration fees, 56% is from preparation factory inspection, 14% is from API factory inspection, and 6% is from DMF declaration fees It has been announced that the approval fees of generic drug declaration in 2013 (October 1, 2012 to September 30, 2013) are as follows: anda declaration: 51520 US dollars pas (pre approval supplementary application) declaration: 25760 US dollars DMF (type II) declaration: 21340 US dollars compiled from: FDA website relevant articles: http://www.ofr.gov/ofrupload/ofrdata/2012-26256 pi.pdf http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf
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