US: FDA User Fee Table for 2020

05-08-2019

US: FDA User Fee Table for 2020

(Source: FDA 2019-08-06)

The US Food and Drug Administration (FDA) has published the user fee for 2020. The fees for each program are as listed below:

 

Prescription Drug User Fee Act (PDUFA VI)
Applications: 2020 2019
     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: 2020 2019
     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)
  2020 2019
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

 

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