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U.S. Department of Health and Human Services

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Accessible Text Version - Standard Costs (in thousands of dollars) for Components of the Process for the Review of Human Drug Applications (FY 2003 - FY 2012)

 

Summary

This table lists the cost1  for each submission type for each fiscal year from 2003 to 2011. For these fiscal years, all are determined from time reporting. The two submission types displayed are drug applications and biologic applications. Drug applications include investigational new drug application (IND), new drug application (NDA) with clinical data - new molecular entity (NME), NDA with clinical data - non-new molecular entity, NDA without clinical data, supplement with clinical data, and supplement without clinical data. Biological applications include investigational new drug application (IND), biologics license application (BLA), product license application (PLA), establishment license application (ELA), supplement with clinical data, and supplement without clinical data.

Row 1. IND, Drug Applications.

Cell 1. Fiscal year 2003.

$299

Cell 2. Fiscal year 2004.

$203.3

Cell 3. Fiscal year 2005.

$240

Cell 4. Fiscal year 2006.

$249.6

Cell 5. Fiscal year 2007.

$284.7

Cell 6. Fiscal year 2008.

$236.5

Cell 7. Fiscal year 2009.

$290.9

Cell 8. Fiscal year 2010.

$362.1

Cell 9. Fiscal year 2011.

$423.3

Cell 10. Fiscal year 2012.

$498.5


Row 2. NDA with Clinical Data - NME, Drug Applications.

Cell 1. Fiscal year 2003.

$2,116

Cell 2. Fiscal year 2004.

$1,987.1

Cell 3. Fiscal year 2005.

$2,456.3

Cell 4. Fiscal year 2006.

$2,986.2

Cell 5. Fiscal year 2007.

$2,250.9

Cell 6. Fiscal year 2008.

$3736.4

Cell 7. Fiscal year 2009.

$4,021.0

Cell 8. Fiscal year 2010.

$4,316.6

Cell 9. Fiscal year 2011.

$5,091.6

Cell 10. Fiscal year 2012.

$3,279.0


Row 3. NDA with Clinical Data - Non-NME, Drug Applications.

Cell 1. Fiscal year 2003.

$746

Cell 2. Fiscal year 2004.

$760.1

Cell 3. Fiscal year 2005.

$684.6

Cell 4. Fiscal year 2006.

$777.1

Cell 5. Fiscal year 2007.

$804.9

Cell 6. Fiscal year 2008.

$1,320.9

Cell 7. Fiscal year 2009.

$1,313.1

Cell 8. Fiscal year 2010.

$1,863.6

Cell 9. Fiscal year 2011.

$2,368.5

Cell 10. Fiscal year 2012.

$1,936.1


Row 4. NDA without Clinical Data, Drug Applications.

Cell 1. Fiscal year 2003.

$561

Cell 2. Fiscal year 2004.

$411.5

Cell 3. Fiscal year 2005.

$476.5

Cell 4. Fiscal year 2006.

$481

Cell 5. Fiscal year 2007.

$239.6

Cell 6. Fiscal year 2008.

$288.7

Cell 7. Fiscal year 2009.

$398.4

Cell 8. Fiscal year 2010.

$502.1

Cell 9. Fiscal year 2011.

$917.1

Cell 10. Fiscal year 2012.

$982.7


Row 5. Supplement with Clinical Data, Drug Applications.

Cell 1. Fiscal year 2003.

$175

Cell 2. Fiscal year 2004.

$142.2

Cell 3. Fiscal year 2005.

$255.4

Cell 4. Fiscal year 2006.

$224.4

Cell 5. Fiscal year 2007.

$247.8

Cell 6. Fiscal year 2008.

$364.0

Cell 7. Fiscal year 2009.

$555.9

Cell 8. Fiscal year 2010.

$615.7

Cell 9. Fiscal year 2011.

$693.7

Cell 10. Fiscal year 2012.

$525.9


Row 6. Supplement without Clinical Data, Drug Applications.

Cell 1. Fiscal year 2003.

$18

Cell 2. Fiscal year 2004.

$16.7

Cell 3. Fiscal year 2005.

$16.5

Cell 4. Fiscal year 2006.

$22.7

Cell 5. Fiscal year 2007.

$19.4

Cell 6. Fiscal year 2008.

$13.8

Cell 7. Fiscal year 2009.

$28.7

Cell 8. Fiscal year 2010.

$31.4

Cell 9. Fiscal year 2011.

$17.8

Cell 10. Fiscal year 2012.

$27.0


Row 7. IND, Biologic Applications.

Cell 1. Fiscal year 2003.

$361

Cell 2. Fiscal year 2004.

$400.4

Cell 3. Fiscal year 2005.

$437.1

Cell 4. Fiscal year 2006.

$393.9

Cell 5. Fiscal year 2007.

$427.5

Cell 6. Fiscal year 2008.

$802.8

Cell 7. Fiscal year 2009.

$860.4

Cell 8. Fiscal year 2010.

$791.9

Cell 9. Fiscal year 2011.

$1,000.8

Cell 10. Fiscal year 2012.

$771.7


Row 8. BLA, Biologic Applications.

Cell 1. Fiscal year 2003.

$4,394

Cell 2. Fiscal year 2004.

$4,074.7

Cell 3. Fiscal year 2005.

$4,492.2

Cell 4. Fiscal year 2006.

$2,626.2

Cell 5. Fiscal year 2007.

$3,141.6

Cell 6. Fiscal year 2008.

$2,726.7

Cell 7. Fiscal year 2009.

$3,529.6

Cell 8. Fiscal year 2010.

$6,081.5

Cell 9. Fiscal year 2011.

$11,203.5

Cell 10. Fiscal year 2012.

$5,905.8


Row 9. PLA, Biologic Applications.

Row 10. ELA, Biologic Applications.


Row 11. Supplement with Clinical Data, Biologic Applications.

Cell 1. Fiscal year 2003.

$228

Cell 2. Fiscal year 2004.

$367.4

Cell 3. Fiscal year 2005.

$239.4

Cell 4. Fiscal year 2006.

$265.2

Cell 5. Fiscal year 2007.

$627.1

Cell 6. Fiscal year 2008.

$511.5

Cell 7. Fiscal year 2009.

$681.8

Cell 8. Fiscal year 2010.

$655.4

Cell 9. Fiscal year 2011.

$661.3

Cell 10. Fiscal year 2012.

$1,166.8


Row 12. Supplement without Clinical Data, Biologic Applications.

Cell 1. Fiscal year 2003.

$21

Cell 2. Fiscal year 2004.

$41

Cell 3. Fiscal year 2005.

$41.9

Cell 4. Fiscal year 2006.

$40.2

Cell 5. Fiscal year 2007.

$53

Cell 6. Fiscal year 2008.

$49.4

Cell 7. Fiscal year 2009.

$68.3

Cell 8. Fiscal year 2010.

$72.8 

Cell 9. Fiscal year 2011.

$83.8

Cell 10. Fiscal year 2012.

$80.4

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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