FDA Announces all User Fees to be Paid by Pharma, Device Industries in 2015
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.
| Activity | |||
|---|---|---|---|
| Prescription Drug User Fee Act (PDUFA) | 2015 | 2014 | 2013 |
| 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) | 2015 | 2014 | 2013 |
| 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) | 2015 | 2014 | 2013 |
| 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) | 2015 | 2014 | 2013 |
| 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) | 2015 | 2014 | 2013 |
| 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) | 2015 | 2014 | 2013 |
| 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 | $88,950 | N/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 Fee | 2015 | 2014 | 2013 |
| Qualified Small Business Establishment Fee | $5,103 | N/A | N/A |
| Non-Small Business Establishment Fee | $16,442 | N/A | N/A |
| Reinspection Fee | $15,308 | N/A | N/A |
Discounts are available for some—but not all—user fees if companies are small or first-time filers.