FDA FY2019 User Fee Table
The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2019 from the manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities that produce compounded drugs. The table below lists the fees for each program:
| Program: | FY2019 | FY2018 |
|---|---|---|
| Prescription Drug User Fee Act (PDUFA VI) | ||
|
Applications: |
|
|
|
Requiring clinical data |
$2,588,478 |
$2,421,495 |
|
Not requiring clinical data |
$1,294,239 |
$1,210,748 |
|
Program fee |
$309,915 |
$304,162 |
| Generic Drug User Fee Amendments (GDUFA II) | ||
|
Applications: |
|
|
|
Abbreviated new drug application (ANDA) |
$178,799 |
$171,823 |
|
Drug master file (DMF) |
$55,013 |
$47,829 |
|
Facilities: |
|
|
|
Active pharmaceutical ingredient (API) – Domestic |
$44,226 |
$45,367 |
|
API – Foreign |
$59,226 |
$60,367 |
|
Finished dosage form (FDF) – Domestic |
$211,305 |
$211,087 |
|
FDF – Foreign |
$226,305 |
$226,087 |
|
Contract manufacturing organization (CMO) – Domestic |
$70,435 |
$70,362 |
|
CMO – Foreign |
$85,435 |
$85,362 |
|
GDUFA program: |
|
|
|
Large size operation generic drug applicant |
$1,862,167 |
$1,590,792 |
|
Medium size operation generic drug applicant |
$744,867 |
$636,317 |
|
Small business operation generic drug applicant |
$186,217 |
$159,079 |
| Biosimilar User Fee Amendments (BSUFA II) | ||
|
Initial biological product development (BPD) |
$185,409 |
$227,213 |
|
Annual BPD |
$185,409 |
$227,213 |
|
Reactivation |
$370,818 |
$454,426 |
|
Applications: |
|
|
|
Requiring clinical data |
$1,746,745 |
$1,746,745 |
|
Not requiring clinical data |
$873,373 |
$873,373 |
|
Program |
$304,162 |
$304,162 |
| Medical Device User Fee Amendments (MDUFA IV) | Standard Fee (Small Business Fee) | |
|
Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act (21 U.S.C. 360e(f), or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)) |
$322,147 ($80,537) |
$310,764 ($77,691) |
|
Premarket report (submitted under section 515(c)(2) of the FD&C Act) |
$322,147 ($80,537) |
$310,764 ($77,691) |
|
Efficacy supplement (to an approved BLA under section 351 of the PHS Act) |
$322,147 ($80,537) |
$310,764 ($77,691) |
|
Panel-track supplement |
$241,610 ($60,403) |
$233,073 ($58,268) |
|
De novo classification request |
$96,644 ($24,161) |
$93,229 ($23,307) |
|
180-day supplement |
$48,322 ($12,081) |
$46,615 ($11,654) |
|
Real-time supplement |
$22,550 ($5,638) |
$21,753 ($5,438) |
|
510(k) premarket notification submission |
$10,953 ($2,738) |
$10,566 ($2,642) |
|
30-day notice |
$5,154 ($2,577) |
$4,972 ($2,486) |
|
513(g) request for classification information |
$4,349 ($2,175) |
$4,195 ($2,098) |
|
Annual fee type |
|
|
|
Annual fee for periodic reporting on a class III device |
$11,275 ($2,819) |
$10,877 ($2,719) |
|
Annual establishment registration fee |
$4,884 ($4,884) |
$4,624 ($4,624) |
| Outsourcing Facility Fees | ||
|
Qualified small business establishment fee |
$5,461 |
$5,364 |
|
Non-small business establishment fee |
$18,375 |
$17,364 |
|
Re-inspection fee |
$16,382 |
$16,093 |
Federal Register: PDUFA, GDUFA, BsUFA, MDUFA, Outsourcing Facilities