Up
2005N-0285:
Current Good Manufacturing Practice Regulation and Investigational
New Drugs
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| NPR1
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| 01/12/2006
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| FDA
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| FDA
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| 01/17/2006
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| 2494-2496
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| 04/03/2006
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| pdf
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| Signature:
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| Jeffrey Shuren
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| NFR1
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| 01/12/2006
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| FDA
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| FDA
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| 01/17/2006
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| 2458-2462
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| pdf
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| Signature:
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| Jeffrey Shuren
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| EMC1
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| 01/17/2006
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| 01/17/2006
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| Individual Consumer
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| B. Sachau
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| EMC2
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| 01/17/2006
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| 01/17/2006
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| Individual Consumer
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| B. Sachau
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| EMC3
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| 01/30/2006
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| 01/30/2006
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| Individual Consumer
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| A. Ragosta
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| C1
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| 02/06/2006
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| 02/01/2006
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| Academia
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| University of Texas
MD Anderson Cancer Center
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| pdf
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| Signature:
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| Lawrence A. Trissel
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| EC1
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| 02/08/2006
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| 02/07/2006
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| Federal Government
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| Ms. Beth Incao
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| htm
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| C2
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| 03/20/2006
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| 03/20/2006
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| Drug Industry
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| Abbott
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| pdf
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| Signature:
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| Zena Kaufman
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| EMC4
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| 03/20/2006
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| 03/20/2006
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| Drug Association
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| Plasma Protein Therapeutics
Association (PPTA)
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| htm
Attachment
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| Signature:
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| Mary Gustafson
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| C3
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| 03/27/2006
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| 03/23/2006
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| Drug Association
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| Plasma Protein Therapeutics
Association (PPTA)
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| pdf
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| Signature:
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| Mary Gustafson
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| C4
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| 03/28/2006
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| 03/28/2006
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| Private Industry
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| FDA Ready Consulting
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| pdf
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| Signature:
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| Gregory Bobrowicz
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| C5
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| 03/30/2006
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| 03/29/2006
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| Association
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| Parenteral Drug Association
(PDA)
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| pdf
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| Signature:
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| Robert B. Myers
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| EC2
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| 04/05/2006
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| 03/02/2006
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| International Public Citizen
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| Mr. Denish Moorthy
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| htm
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| Signature:
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| Moorthy, Denish
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| EC3
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| 04/05/2006
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| 03/29/2006
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| Drug Association
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| PDA
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| pdf
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| Signature:
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| Dana, Robert
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| EC4
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| 04/05/2006
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| 04/03/2006
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| Private Industry
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| Immel Resources LLC
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| Attachment,
Copyrighted Material
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| Signature:
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| Immel, Barbara
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| EC5
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| 04/05/2006
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| 04/03/2006
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| Drug Industry
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| Novartis Pharmaceuticals
Corp.
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| Attachment
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| Signature:
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| Greene, Kathleen
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| EC6
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| 04/05/2006
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| 04/03/2006
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| Consumer Group
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| Public Citizen's Health
Research Group
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| Attachment
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| Signature:
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| Wolfe, Sidney
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| C6
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| 04/03/2006
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| 03/31/2006
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| Private Industry
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| Cambrex
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| pdf
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| Signature:
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| Barbara B Zinck
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| C7
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| 04/03/2006
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| 04/03/2006
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| Private Industry
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| Immel Resource LLC
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| pdf
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| Signature:
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| Barbara Immel
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| C8
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| 04/21/2006
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| 04/20/2006
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| Drug Industry
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| Bristol-Myers Squibb
Company (BMS)
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| pdf
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| Signature:
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| Richard L. Wolgemuth, PhD
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| NWL1
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| 05/01/2006
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| FDA
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| FDA
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| 05/02/2006
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| 25747-25747
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|
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| txt
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| EFF 5/2/06
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| Signature:
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| Jeffrey Shuren
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| C9
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| 06/06/2006
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| 05/31/2006
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| Private Industry
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| Bernstein CMC Regulatory
Consulting
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| pdf
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| Signature:
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| David Bernstein, PhD
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Top | Up
Page last updated
June 14, 2006
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