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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 1993 - FY 2002)

Summary

This table lists the cost for each submission type for each fiscal year from 1993 to 2002. For fiscal years 1993 through 2000, all are determined on the basis of the Arthur Andersen model developed in 1993. The KPMG model is used for fiscal years 2001 and 2002. 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 1993.

$70

Cell 2. Fiscal year 1994.

$79

Cell 3. Fiscal year 1995.

$98

Cell 4. Fiscal year 1996.

$97

Cell 5. Fiscal year 1997.

$84

Cell 6. Fiscal year 1998.

$94

Cell 7. Fiscal year 1999.

$105

Cell 8. Fiscal year 2000.

$119

Cell 9. Fiscal year 2001.

$200

Cell 10. Fiscal year 2002.

$211.8

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

Cell 1. Fiscal year 1993.

$887

Cell 2. Fiscal year 1994.

$1,004

Cell 3. Fiscal year 1995.

$1,243

Cell 4. Fiscal year 1996.

$1,233

Cell 5. Fiscal year 1997.

$1,065

Cell 6. Fiscal year 1998.

$1,194

Cell 7. Fiscal year 1999.

$1,328

Cell 8. Fiscal year 2000.

$1,503

Cell 9. Fiscal year 2001.

$1,920

Cell 10. Fiscal year 2002.

$2,037.0

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

Cell 1. Fiscal year 1993.

$298

Cell 2. Fiscal year 1994.

$337

Cell 3. Fiscal year 1995.

$417

Cell 4. Fiscal year 1996.

$414

Cell 5. Fiscal year 1997.

$358

Cell 6. Fiscal year 1998.

$401

Cell 7. Fiscal year 1999.

$446

Cell 8. Fiscal year 2000.

$505

Cell 9. Fiscal year 2001.

$929

Cell 10. Fiscal year 2002.

$985.9

Row 4. NDA without Clinical Data, Drug Applications.

Cell 1. Fiscal year 1993.

$127

Cell 2. Fiscal year 1994.

$144

Cell 3. Fiscal year 1995.

$178

Cell 4. Fiscal year 1996.

$177

Cell 5. Fiscal year 1997.

$152

Cell 6. Fiscal year 1998.

$171

Cell 7. Fiscal year 1999.

$190

Cell 8. Fiscal year 2000.

$215

Cell 9. Fiscal year 2001.

$261

Cell 10. Fiscal year 2002.

$276.6

Row 5. Supplement with Clinical Data, Drug Applications.

Cell 1. Fiscal year 1993.

$151

Cell 2. Fiscal year 1994.

$171

Cell 3. Fiscal year 1995.

$212

Cell 4. Fiscal year 1996.

$210

Cell 5. Fiscal year 1997.

$181

Cell 6. Fiscal year 1998.

$203

Cell 7. Fiscal year 1999.

$226

Cell 8. Fiscal year 2000.

$256

Cell 9. Fiscal year 2001.

$111

Cell 10. Fiscal year 2002.

$118.1

Row 6. Supplement without Clinical Data, Drug Applications.

Cell 1. Fiscal year 1993.

$6

Cell 2. Fiscal year 1994.

$7

Cell 3. Fiscal year 1995.

$8

Cell 4. Fiscal year 1996.

$8

Cell 5. Fiscal year 1997.

$7

Cell 6. Fiscal year 1998.

$8

Cell 7. Fiscal year 1999.

$9

Cell 8. Fiscal year 2000.

$10

Cell 9. Fiscal year 2001.

$8

Cell 10. Fiscal year 2002.

$8.1

Row 7. IND, Biologic Applications.

Cell 1. Fiscal year 1993.

$184

Cell 2. Fiscal year 1994.

$230

Cell 3. Fiscal year 1995.

$234

Cell 4. Fiscal year 1996.

$266

Cell 5. Fiscal year 1997.

$204

Cell 6. Fiscal year 1998.

$173

Cell 7. Fiscal year 1999.

$243

Cell 8. Fiscal year 2000.

$175

Cell 9. Fiscal year 2001.

$287

Cell 10. Fiscal year 2002.

$278.9

Row 8. BLA, Biologic Applications.

Cell 1. Fiscal year 1998.

$1,118

Cell 2. Fiscal year 1999.

$1,568

Cell 3. Fiscal year 2000.

$1,128

Cell 4. Fiscal year 2001.

$2,788

Cell 5. Fiscal year 2002.

$2,708.2

Row 9. PLA, Biologic Applications.

Cell 1. Fiscal year 1993.

$1,078

Cell 2. Fiscal year 1994.

$1,345

Cell 3. Fiscal year 1995.

$1,369

Cell 4. Fiscal year 1996.

$1,560

Cell 5. Fiscal year 1997.

$1,194

Cell 6. Fiscal year 1998.

$1,016

Cell 7. Fiscal year 1999.

$1,426

Cell 8. Fiscal year 2000.

$1,026

Row 10. ELA, Biologic Applications.

Cell 1. Fiscal year 1993.

$177

Cell 2. Fiscal year 1994.

$221

Cell 3. Fiscal year 1995.

$225

Cell 4. Fiscal year 1996.

$256

Cell 5. Fiscal year 1997.

$196

Cell 6. Fiscal year 1998.

$167

Cell 7. Fiscal year 1999.

$234

Cell 8. Fiscal year 2000.

$168

Row 11. Supplement with Clinical Data, Biologic Applications.

Cell 1. Fiscal year 1993.

$561

Cell 2. Fiscal year 1994.

$700

Cell 3. Fiscal year 1995.

$713

Cell 4. Fiscal year 1996.

$812

Cell 5. Fiscal year 1997.

$622

Cell 6. Fiscal year 1998.

$529

Cell 7. Fiscal year 1999.

$742

Cell 8. Fiscal year 2000.

$534

Cell 9. Fiscal year 2001.

$195

Cell 10. Fiscal year 2002.

$189.6

Row 12. Supplement without Clinical Data, Biologic Applications.

Cell 1. Fiscal year 1993.

$34

Cell 2. Fiscal year 1994.

$42

Cell 3. Fiscal year 1995.

$43

Cell 4. Fiscal year 1996.

$49

Cell 5. Fiscal year 1997.

$38

Cell 6. Fiscal year 1998.

$32

Cell 7. Fiscal year 1999.

$45

Cell 8. Fiscal year 2000.

$32

Cell 9. Fiscal year 2001.

$31

Cell 10. Fiscal year 2002.

$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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