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FDA increases generic drug user fees in 2014 Posted 23/08/2013

FDA has increased the amount that generics manufacturers will have to pay to register their finished drug formulation (FDF) facilities by more than US$40,000 for 2014 compared to 2013.

The increases were announced by FDA in an August 2013 Federal Register Notice. Active pharmaceutical ingredient (API) manufacturers will also see an increase in fees of more than US$8,000.

The fees come as part of the Generic Drug User Fee Amendments of 2012 (GDUFA), which was approved by the US Congress on 21 September 2012 [1].

The fiscal year 2014 fees for FDF and API facilities for US and foreign generics manufacturers, which are due on 1 October 2014, are: 




Domestic FDF facility:



Foreign FDF facility:



Domestic API facility:



Foreign API facility:



The extra cost for non-US manufacturers has been kept the same as in 2013, as being US$15,000 more than domestic facilities. This has been calculated by FDA to be sufficient to cover the higher costs of inspecting foreign facilities.

A total of 748 FDF facilities have self-identified, which includes 315 US facilities and 433 foreign facilities. For APIs 903 manufacturers have self-identified, which includes 128 US API sites and 775 foreign API sites.

The fees for abbreviated new drug applications (ANDAs), Prior Approval Supplements (PASs) and Drug Master Files (DMFs) have also been increased by as much as 48% from those in 2013. The new fees for fiscal year 2014 for ANDAs is US$63,860, the PAS fee is US$31,930 and the DMF fee is US$31,460.

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1.  GaBI Online - Generics and Biosimilars Initiative. Generic drug user fees come into effect [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Aug 23]. Available from: www.gabionline.net/Policies-Legislation/Generic-drug-user-fees-come-into-effect

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Source: FDA

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