New Drug Microbial Safety Review Under Guidance #152
DoubleTree Hotel
Plaza Ballroom III
October 13, 2004
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8:30 – 8:40 |
Welcome |
Stephen Sundlof | |
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8:40 – 8:50 |
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Brief Background for Today’s Discussion |
Linda Tollefson |
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8:50– 9:20 |
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Importance of Macrolides to Human Medicine |
John Powers |
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9:20 – 9:50 |
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Importance of Macrolides to Animal Medicine |
Mike Apley |
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9:50 – 10:30 |
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Drug Product Presentation |
Scott Brown |
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10:30 – 10:45 |
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Break |
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10:45 – 11:00 |
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CVM Response/Comments |
Jeff Gilbert |
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11:00– 12:00 |
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Open Public Hearing |
Aleta Sindelar |
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12:00 – 1:00 |
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Lunch |
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1:00 – 1:15 |
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VMAC Questions: Clarifications |
Jeff Gilbert |
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1:15 – 2:45 |
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VMAC Deliberations |
John Waddell |
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2:45– 3:00 |
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Break |
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4:45 – 5:00 |
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Concluding Remarks, Next Steps and Adjourn |
Linda Tollefson |
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