Estimates Made Pursuant to Section 736(d)(2) of the Federal Food, Drug, and Cosmetic Act |
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| From Time Rpt. |
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Submission Type | FY 03 | FY 04 | FY 05 | FY 06 | FY 07 | FY 08 | FY 09 | FY 10 | FY 11 |
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Drug Applications |
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IND | $299 | $203.3 | $240 | $249.6 | $284.7 | $236.5 | $290.9 | $362.1 | $423.3 |
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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 |
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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 |
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NDA without Clinical Data | $561 | $411.5 | $476.5 | $481 | $239.6 | $288.7 | $398.4 | $502.1 | $917.1 |
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Supplement with Clinical Data | $175 | $142.2 | $255.4 | $224.4 | $247.8 | $364.0 | $555.9 | $615.7 | $693.7 |
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Supplement without Clinical Data | $18 | $16.7 | $16.5 | $22.7 | $19.4 | $13.8 | $28.7 | $31.4 | $17.8 |
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Biologic Applications |
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IND | $361 | $400.4 | $437.1 | $393.9 | $427.5 | $802.8 | $860.4 | $791.9 | $1,000.8 |
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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 |
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PLA | | | | | | | | | |
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ELA | | | | | | | | | |
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Supplement with Clinical Data | $228 | $367.4 | $239.4 | $265.2 | $627.1 | $511.5 | $681.8 | $655.4 | $661.3 |
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Supplement without Clinical Data | $21 | $41 | $41.9 | $40.2 | $53 | $49.4 | $68.3 | $72.8 | $83.8 |
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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. |