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FDA Projects Increased Submissions, Fewer Approvals In FY 2006, 2007

Executive Summary

FDA predicts an increase in applications over the next two years will not translate into more approvals within the fiscal 2006 and 2007 timeframe

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NDA filings hold steady

The 116 NDAs received by CDER in calendar year 2005 continues a trend of modest growth since a user fee-era low of 98 NDAs received in 2001. The 2005 figure is comparable to the 115 NDA receipts in 2004, which was a modest bump from 109 in 2003 due to the transfer of therapeutic biologics to CDER in October 2003. The numbers have been revised from last year's figures, likely due to reclassification of the submissions; the previous NDA receipts were recorded as 103 for 2004 and 110 for 2003 (1"The Pink Sheet" April 4, 2005, p. 14). FDA has predicted continued modest growth in applications in fiscal 2006 and 2007, but the agency cautions that it does not expect high NDA receipts to translate into more approval (2"The Pink Sheet" Feb. 13, 2006, p. 6) ...

NDA filings hold steady

The 116 NDAs received by CDER in calendar year 2005 continues a trend of modest growth since a user fee-era low of 98 NDAs received in 2001. The 2005 figure is comparable to the 115 NDA receipts in 2004, which was a modest bump from 109 in 2003 due to the transfer of therapeutic biologics to CDER in October 2003. The numbers have been revised from last year's figures, likely due to reclassification of the submissions; the previous NDA receipts were recorded as 103 for 2004 and 110 for 2003 (1"The Pink Sheet" April 4, 2005, p. 14). FDA has predicted continued modest growth in applications in fiscal 2006 and 2007, but the agency cautions that it does not expect high NDA receipts to translate into more approval (2"The Pink Sheet" Feb. 13, 2006, p. 6) ...

PDUFA IV: FDA Stresses Burden Of Industry Meetings In User Fee Discussions

FDA is emphasizing the difficulties of industry requested meetings in its early public discussion of the 2007 Prescription Drug User Fee Act reauthorization

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