The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a more timely manner. The solution FDA proposed was to collect one-time fees from the companies it regulates for each new drug approval, which would provide the agency with a substantial source of funding to boost its staff and reduce review times.
Eventually, this led to the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, which authorized FDA to collect fees for its review activities in return for a speedier, more predictable review process.
Since then, Congress has enacted many other user fee acts covering medical devices, generic drugs, animal drugs and biosimilars, as well as related inspection and registration activities.
FY2016 Fees
Each year, FDA adjusts the rates of these fees to keep up with inflation and the agencys workload. The table below shows the rates to be charged for FY2016, which take effect on 1 October 2015.
**Activity** **Prescription Drug User Fee Act (PDUFA)** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18914/prescription-drug-user-fee-rates-for-fiscal-year-2016)** **[2015](https://www.federalregister.gov/articles/2014/08/01/2014-18113/prescription-drug-user-fee-rates-for-fiscal-year-2015)** **[2014](https://www.federalregister.gov/articles/2013/08/02/2013-18624/prescription-drug-user-fee-rates-for-fiscal-year-2014)** New Drug Application (With Clinical Data) $2,374,200 $2,335,200 $2,169,100 New Drug Application (Without Clinical Data) $1,187,100 $1,167,600 $1,084,550 New Drug Application Supplement With Clinical Data $1,187,100 $1,167,600 $1,084,550 NDA Establishment $585,200 $569,200 $554,600 Annual Product Registration $114,450 $110,370 $104,060 **Medical Device User Fee Act (MDUFA)** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18907/medical-device-user-fee-rates-for-fiscal-year-2016)** **[2015](https://www.federalregister.gov/articles/2014/07/30/2014-17902/medical-device-user-fee-rates-for-fiscal-year-2015?utm_campaign=pi+subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov)** **[2014](https://www.federalregister.gov/articles/2013/08/02/2013-18623/medical-device-user-fee-rates-for-fiscal-year-2014)** Premarket Application $261,388 $250,895 $258,520 Product Development Protocol $261,388 $250,895 $258,520 Biologics Licensing Application $261,388 $250,895 $258,520 Premarket Report $261,388 $250,895 $258,520 BLA Efficacy Supplement $261,388 $250,895 $258,520 Panel-Track Supplement $196,041 $188,171 $193,890 180-Day Supplement $39,208 $37,634 $38,778 Real-Time Supplement $18,297 $17,563 $18,096 510(k) Premarket Notification Submission $5,228 $5,018 $5,170 30-Day Notice $4,182 $4,014 $4,136 513(g) Request for Classification Information $3,529 $3,387 $3,490 Annual Fee for Class III Device $9,149 $8,781 $9,048 Annual Establishment Registration $3,845 $3,646 $3,313 **Generic Drug User Fee Act (GDUFA)** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18915/generic-drug-user-fee-abbreviated-new-drug-application-prior-approval-supplement-drug-master-file)** **[2015](https://www.federalregister.gov/articles/2014/08/01/2014-18108/generic-drug-user-fee-abbreviated-new-drug-application-prior-approval-supplement-drug-master-file)** **[2014](https://www.federalregister.gov/articles/2013/08/02/2013-18625/generic-drug-user-fee-abbreviated-new-drug-application-prior-approval-supplement-drug-master-file)** Abbreviated New Drug Application $76,030 $58,730 $63,860 Prior Approval Supplement $38,020 $29,370 $31,930 Drug Master File $42,170 $26,720 $31,460 Finished Dosage Form Facility (Domestic) $243,905 $247,717 $220,152 Finished Dosage Form Facility (Foreign) $258,905 $262,717 $235,152 Active Pharmaceutical Ingredient Facility (Domestic) $40,867 $41,926 $34,515 Active Pharmaceutical Ingredient Facility (Foreign) $55,867 $56,926 $49,515 **Biosimilar User Fee Act (BsUFA)** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18908/biosimilar-user-fee-rates-for-fiscal-year-2016)** **[2015](https://www.federalregister.gov/articles/2014/08/01/2014-18112/biosimilar-user-fee-rates-for-fiscal-year-2015)** **[2014](https://www.federalregister.gov/articles/2013/08/02/2013-18621/biosimilar-user-fee-rates-for-fiscal-year-2014)** Biosimilar Application (Requiring Clinical Data) $2,374,200 $2,335,200 $2,169,100 Biosimilar Application (Not Requiring Clinical Data) $1,187,100 $1,167,600 $1,084,550 Biosimilar Supplement (Requiring Clinical Data) $1,187,100 $1,167,600 $1,084,550 Biological Product Development (Initial) $237,420 $233,520 $216,910 Biological Product Development (Annual) $237,420 $233,520 $216,910 Biological Product Development (Reactivation) $474,840 $467,040 $433,820 Establishment Fee $585,200 $569,200 $554,600 Product Fee $114,450 $110,370 $104,060 **Animal Drug User Fee Act (ADUFA)** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18913/animal-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2016)** **[2015](https://www.federalregister.gov/articles/2014/08/01/2014-18110/animal-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2015)** **[2014](https://www.federalregister.gov/articles/2013/08/02/2013-18619/animal-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2014)** Animal Drug Application (New) $351,100 $400,600 $396,600 Animal Drug Application (Supplement) $175,550 $200,300 $198,300 Animal Drug Product Fee $7,790 $8,075 $9,075 Animal Drug Establishment Fee $105,950 $104,150 $105,800 Animal Drug Sponsor Fee $101,000 $94,450 $101,150 **Animal Generic Drug User Fee Act (AGDUFA)** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18909/animal-generic-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2016)** **[2015](https://www.federalregister.gov/articles/2014/08/01/2014-18178/animal-generic-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2015)** **[2014](https://www.federalregister.gov/articles/2013/08/02/2013-18620/animal-generic-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2014)** Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4) $233,300 $189,200 $177,900 Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) $116,650 $94,600 $88,950 Generic New Animal Drug Product Fee $8,705 $8,500 $8,035 Sponsor Fee (Seven or More Approved Products) $83,800 $80,900 $72,800 Sponsor Fee (Three or More Approved Products) $62,850 $60,675 $54,600 Sponsor Fee (One or Fewer Approved Products) $41,900 $40,450 $36,400 **Outsourcing Facility Fee** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18916/outsourcing-facility-fee-rates-for-fiscal-year-2016)** **[2015](https://www.federalregister.gov/articles/2014/08/01/2014-18111/outsourcing-facility-fee-rates-for-fiscal-year-2015)** **2014** Qualified Small Business Establishment Fee $5,203 $5,103 N/A Non-Small Business Establishment Fee $16,465 $16,442 N/A Reinspection Fee $15,610 $15,308 N/A
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