FDA has announced User Fee for FY2020

The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2020 from the manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities that produce compounded drugs.

The below table shows the detail list of fees for each program:

Program: FY2020 FY2019
Prescription Drug User Fee Act (PDUFA VI)
Applications:
     Requiring clinical data $2,942,965 $2,588,478
     Not requiring clinical data $1,471,483 $1,294,239
Program fee $325,424 $309,915
Generic Drug User Fee Amendments (GDUFA II)
Applications:
     Abbreviated new drug application (ANDA) $176,237 $178,799
     Drug master file (DMF) $57,795 $55,013
Facilities:
     Active pharmaceutical ingredient (API) – Domestic $44,400 $44,226
     API – Foreign $59,400 $59,226
     Finished dosage form (FDF) – Domestic $195,662 $211,305
     FDF – Foreign $210,662 $226,305
     Contract manufacturing organization (CMO) – Domestic $65,221 $70,435
     CMO – Foreign $80,221 $85,435
GDUFA program:
     Large size operation generic drug applicant $1,661,684 $1,862,167
     Medium size operation generic drug applicant $664,674 $744,867
     Small business operation generic drug applicant $166,168 $186,217
Biosimilar User Fee Amendments (BSUFA II)
Initial biological product development (BPD) $117,987 $185,409
Annual BPD $117,987 $185,409
Reactivation $235,975 $370,818
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)) $340,995 ($85,249) $322,147 ($80,537)
Premarket report (submitted under section 515(c)(2) of the FD&C Act) $340,995 ($85,249) $322,147 ($80,537)
Efficacy supplement (to an approved BLA under section 351 of the PHS Act) $340,995 ($85,249) $322,147 ($80,537)
Panel-track supplement $255,747 ($63,937) $241,610 ($60,403)
De novo classification request $102,299 ($25,575) $96,644 ($24,161)
180-day supplement $51,149 ($12,787) $48,322 ($12,081)
Real-time supplement $23,870 ($5,968) $22,550 ($5,638)
510(k) premarket notification submission $11,594 ($2,899) $10,953 ($2,738)
30-day notice $5,456   ($2,728) $5,154 ($2,577)
513(g) requests for classification information $4,603 ($2,302) $4,349 ($2,175)
Annual fee type
     Annual fee for periodic reporting on a class III device $11,935 ($2,984) $11,275 ($2,819)
Annual establishment registration fee $5,236   ($5,236) $4,884 ($4,884)
Outsourcing Facility Fees
Qualified small business establishment fee $5,599 $5,461
Non-small business establishment fee $18,288 $18,375
Re-inspection fee $16,798 $16,382