For Industry

Standard Costs (in thousands of dollars) for Components of the Process for the Review of Human Drug Applications

Revised to Incorporate FY 2012 Standard Costs

Previous years (FY 1993 - FY 2002) 

 

Accessible text                                                          FY 2003 - FY 2013

 Estimates Made Pursuant to Section 736(d)(2) of the Federal Food, Drug, and Cosmetic Act

  From Time Rpt.  
Submission Type FY 03 FY 04 FY 05 FY 06 FY 07 FY 08 FY 09 FY 10 FY 11 FY 12 FY 13
Drug Applications     
IND $299 $203.3 $240 $249.6 $284.7 $236.5 $290.9 $362.1 $423.3 $498.5 $449.5
NDA with Clinical Data - NME $2,116 $1,987.1 $2,456.3 $2,986.2 $2,250.9 $3,736.4 $4,021.0 $4,316.6 $5,091.6 $3,279.0 $5,122.0
NDA with Clinical Data - Non-NME $746 $760.1 $684.6 $777.1 $804.9 $1,320.9 $1,313.1 $1,863.6 $2,368.5 $1,936.1 $1,474.7
NDA without Clinical Data $561 $411.5 $476.5 $481 $239.6 $288.7 $398.4 $502.1 $917.1 $982.7 $1,020.7
Supplement with Clinical Data $175 $142.2 $255.4 $224.4 $247.8 $364.0 $555.9 $615.7 $693.7 $525.9 $372.3
Supplement without Clinical Data $18 $16.7 $16.5 $22.7 $19.4 $13.8 $28.7 $31.4 $17.8 $27.0 $49.8
Biologic Applications  
IND $361 $400.4 $437.1 $393.9 $427.5 $802.8 $860.4 $791.9 $1,000.8 $771.7 $550.7
BLA $4,394 $4,074.7 $4,492.2 $2,626.2 $3,141.6 $2,726.7 $3,529.6 $6,081.5 $11,203.5 $5,905.8 $4,089.8
PLA                      
ELA                      
Supplement with Clinical Data $228 $367.4 $239.4 $265.2 $627.1 $511.5 $681.8 $655.4 $661.3 $1,166.8 $459.0
Supplement without Clinical Data $21 $41 $41.9 $40.2 $53 $49.4 $68.3 $72.8 $83.8 $80.4 $78.1
1 Standard costs include all costs associated with application review, including rent, overhead, and centrally funded costs. Method revised in FY 2001-2002 based on KPMG study, and in 2003 on time reporting data. Time reporting method revised with better allocation of indirect cost beginning in 2004.

Accessible text                                                     FY 1993 - FY 2002

 Estimates Made Pursuant to Section 736(d)(2)of the Federal Food, Drug, and Cosmetic Act

  All determined on the basis of the Arthur Andersen model developed in 1993 KPMG Model
Submission Type FY 93 FY 94 FY 95 FY 96 FY 97 FY 98 FY 99 FY 00 FY 01 FY 02
Drug Applications
IND $70 $79 $98 $97 $84 $94 $105 $119 $200 $211.8
NDA with Clinical Data - NME $887 $1,004 $1,243 $1,233 $1,065 $1,194 $1,328 $1,503 $1,920 $2,037.0
NDA with Clinical Data - Non-NME $298 $337 $417 $414 $358 $401 $446 $505 $929 $985.9
NDA without Clinical Data $127 $144 $178 $177 $152 $171 $190 $215 $261 $276.6
Supplement with Clinical Data $151 $171 $212 $210 $181 $203 $226 $256 $111 $118.1
Supplement without Clinical Data $6 $7 $8 $8 $7 $8 $9 $10 $8 $8.1
Biologic Applications
IND $184 $230 $234 $266 $204 $173 $243 $175 $287 $278.9
BLA           $1,118 $1,568 $1,128 $2,788 $2,708.2
PLA $1,078 $1,345 $1,369 $1,560 $1,194 $1,016 $1,426 $1,026    
ELA $177 $221 $225 $256 $196 $167 $234 $168    
Supplement with Clinical Data $561 $700 $713 $812 $622 $529 $742 $534 $195 $189.6
Supplement without Clinical Data $34 $42 $43 $49 $38 $32 $45 $32 $31 $29.8
1 Standard costs include all costs associated with application review, including rent, overhead, and centrally funded costs. Method revised in FY 2001-2002 based on KPMG study, and in 2003 on time reporting data. Time reporting method revised with better allocation of indirect cost beginning in 2004.

 

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