SummaryThis 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 2014$459.0
Row 2. NDA with Clinical Data - NME, Drug Applications.
Cell 1. Fiscal year 2014$5646.4
Row 3. NDA with Clinical Data - Non-NME, Drug Applications.
Cell 1. Fiscal year 2014$1,845.2
Row 4. NDA without Clinical Data, Drug Applications.
Cell 1. Fiscal year 2014$757.6
Row 5. Supplement with Clinical Data, Drug Applications.
Cell 1. Fiscal year 2014$337.8
Row 6. Supplement without Clinical Data, Drug Applications.
Cell 1. Fiscal year 2014$75.9
Row 7. IND, Biologic Applications.
Cell 1. Fiscal year 2003.$602.3
Row 8. BLA, Biologic Applications.
Cell 1. Fiscal year 2014$5,533.5
Row 9. PLA, Biologic Applications.
Row 10. ELA, Biologic Applications.
Row 11. Supplement with Clinical Data, Biologic Applications.
Cell 1. Fiscal year 2014$401.3
Row 12. Supplement without Clinical Data, Biologic Applications.
Cell 1. Fiscal year 2014.$83.9 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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