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1
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- November 10, 2004
- IVD Roundtable
- Mary Elizabeth Jacobs, Ph.D.
- OBRR, CBER
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2
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- To the MDUFMA Stakeholders meeting
- November 18, 2004
- Register online
- Marriott Gaithersburg Washingtonian Center
- FDA/Industry panels
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3
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- MDUFMA goals
- MDUFMA Stakeholder Meeting
- Work with OIVD/CDRH
- Critical Path
- Three BPAC meetings/year
- Communication
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4
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- ISO accreditation
- Review Management
- Training initiatives
- Electronic Document Room
- OCTGT Director: Edward Otto, Ph.D.
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5
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- Number going up for CBER
- Totals
- FY 01 37
- FY 02 41
- FY 03 66
- FY 04 78
- FY 05 ?
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6
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- FDA time Total time
- (days, Avg)* (days, Avg)*
- Traditional 68.9 86.0
- Abbreviated 74.0 96.8
- Special 26.6 26.6
- Total (64/77) 65.1 81.3
- * Times may increase with completions of pendings
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7
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- SE/NSE Av* Rev 1st
- Traditional 46 1.3 3 5
- Abbreviated 11 1.55 0 0
- Special 7 1.00 0 0
- Total 64 1.31 3 5
- *Average may increase with completion of pendings
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8
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