FDA Unveils User Fee Rates for FY2016

Regulatory NewsRegulatory News | 04 August 2015 |  By 

In the 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for FDA itself.

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 agency's workload. The table below shows the rates to be charged for FY2016, which take effect on 1 October 2015.

Prescription Drug User Fee Act (PDUFA)201620152014
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)201620152014
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)201620152014
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)201620152014
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)201620152014
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)201620152014
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 Fee201620152014
Qualified Small Business Establishment Fee$5,203$5,103N/A
Non-Small Business Establishment Fee$16,465$16,442N/A
Reinspection Fee$15,610$15,308N/A


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