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FDA FY2019 User Fee Table

Posted 31 July 2018 | By Michael Mezher 

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


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