FDA Announces Generic Drug User Fees for FY 2013
The Food and Drug Administration announced its fiscal year 2013 abbreviated new drug application (ANDA), prior approval supplement (PAS), drug master file (DMF), and backlog fees, pursuant to the Generic Drug User Fee Amendments (GDUFA) of 2012. The fees are effective Oct. 1, 2012, and will run until Sept. 30, 2013. Going forward, FDA will publish GDUFA fees 60 days prior to the beginning of each fiscal year, it said. GDUFA fees are expected to generate $299 million annually for FDA. The fees will be used to conduct activities such as increased inspections of foreign facilities.
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The ANDA fees ($51,520) and PAS fees ($25,760) are owed by each applicant that submits an ANDA or PAS on or after Oct. 1. The fees are due on the date of submission or 30 days after the Oct. 25 publication date of FDA’s notice, whichever is later.
The DMF fee ($21,340) is owed by each person that owns a type II active pharmaceutical ingredient drug master file that is referenced, on or after Oct. 1, in a generic drug submission by an initial letter of authorization. The DMF fee is a one-time fee for each individual DMF, after which the DMF will be placed on a publicly available list documenting DMFs available for reference.
The backlog fee ($17,434) will be assessed one time only on each person that owns an abbreviated new drug application that is pending on Oct. 1, and that has not received a tentative approval prior to that date. No backlog fee will be assessed in future years.
FDA notice on ANDA, PAS, and DMF fees is available here.
FDA notice on backlog fees is available here.