FDA Announces all User Fees to be Paid by Pharma, Device Industries in 2015

Posted 01 August 2014 By Alexander Gaffney, RAC


The US Food and Drug Administration (FDA) has now released all user fee amounts for the coming 2015 Fiscal Year, including fees for medical devices, pharmaceuticals, generic drugs, biosimilar drugs, drugs compounded at outsourcing facilities, animal drugs and generic animal drugs.

The current FY 2014 user fees are also displayed, as are fees from FY 2013, when most programs were overhauled under the Food and Drug Administration Safety and Innovation Act (FDASIA).

This is the first year that outsourcing facility user fees have been listed by FDA.

Prescription Drug User Fee Act (PDUFA)201520142013
New Drug Application (With Clinical Data)$2,335,200$2,169,100$1,958,800
New Drug Application (Without Clinical Data)$1,167,600$1,084,550$979,400
New Drug Application Supplement With Clinical Data$1,167,600$1,084,550$979,400
NDA Establishment$569,200$554,600$526,500
Annual Product Registration$110,370$104,060$98,380
Medical Device User Fee Act (MDUFA)201520142013
Premarket Application$250,895$258,520$248,000
Product Development Protocol$250,895$258,520$248,000
Biologics Licensing Application$250,895$258,520$248,000
Premarket Report$250,895$258,520$248,000
BLA Efficacy Supplement$250,895$258,520$248,000
Panel-Track Supplement$188,171$193,890$186,000
180-Day Supplement$37,634$38,778$37,200
Real-Time Supplement$17,563$18,096$17,360
510(k) Premarket Notification Submission$5,018$5,170$4,960
30-Day Notice$4,014$4,136$3,968
513(g) Request for Classification Information$3,387$3,490$3,348
Annual Fee for Class III Device$8,781$9,048$8,680
Annual Establishment Registration$3,646$3,313$2,575
Generic Drug User Fee Act (GDUFA)201520142013
Abbreviated New Drug Application$58,730$63,860$51,520
Prior Approval Supplement$29,370$31,930$25,760
Drug Master File$26,720$31,460$21,340
Finished Dosage Form Facility (Domestic)$247,717$220,152$175,389
Finished Dosage Form Facility (Foreign)$262,717$235,152$190,389
Active Pharmaceutical Ingredient Facility (Domestic)$41,926$34,515$26,458
Active Pharmaceutical Ingredient Facility (Foreign)$56,926$49,515$41,458
Biosimilar User Fee Act (BsUFA)201520142013
Biosimilar Application (Requiring Clinical Data)$2,335,200$2,169,100$1,958,800
Biosimilar Application (Not Requiring Clinical Data)$1,167,600$1,084,550$979,400
Biosimilar Supplement (Requiring Clinical Data)$1,167,600$1,084,550$979,400
Biological Product Development (Initial)$233,520$216,910$195,880
Biological Product Development (Annual)$233,520$216,910$195,880
Biological Product Development (Reactivation)$467,040$433,820$391,760
Establishment Fee$569,200$554,600$526,500
Product Fee$110,370$104,060$98,380
Animal Drug User Fee Act (ADUFA)201520142013
Animal Drug Application (New)$400,600$396,600$435,200
Animal Drug Application (Supplement)$200,300$198,300$217,600
Animal Drug Product Fee$8,075$9,075$8,640
Animal Drug Establishment Fee$104,150$105,800$104,600
Animal Drug Sponsor Fee$94,450$101,150$87,700
Animal Generic Drug User Fee Act (AGDUFA)201520142013
Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4)$189,200$177,900$148,300
Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4)$94,600$88,950N/A
Generic New Animal Drug Product Fee$8,500$8,035$6,515
Sponsor Fee (Seven or More Approved Products)$80,900$72,800$63,000
Sponsor Fee (Three or More Approved Products)$60,675$54,600$47,250
Sponsor Fee (One or Fewer Approved Products)$40,450$36,400$31,500
Outsourcing Facility Fee201520142013
Qualified Small Business Establishment Fee$5,103N/AN/A
Non-Small Business Establishment Fee$16,442N/AN/A
Reinspection Fee$15,308N/AN/A

Discounts are available for some—but not all—user fees if companies are small or first-time filers.

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Categories: Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Veterinary products, Submission and registration, News, US, CBER, CDER, CDRH

Tags: PDUFA, MDUFA, BsUFA, GDUFA, ADUFA, AGDUFA, Outsourcing Fee, User Fee, FDA User Fees, FY 2015 User Fees

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