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2003P-0176:
Follow-On Approval of Therapeutic Protein Products
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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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| CP1
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| 04/23/2003
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| 04/24/2003
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| Private Industry
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| Biotechnology Industry
Organization
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| pdf
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| ACK: 4/25/03
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| Signature:
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| Stephen E. Lawton
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| ACK1
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| 04/25/2003
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| 04/25/2003
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| Other Organization
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| HFA-305 to BIO
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| pdf
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| Signature:
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| Jennie Butler
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| EMC1
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| 08/08/2003
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| 08/08/2003
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| Private Industry
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| Biotechnology Industry
Organization
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| pdf
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| Signature:
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| Stephan E Lawton, Gillian R
Woollett
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| C1
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| 10/22/2004
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| 10/12/2004
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| Academia
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| University of California
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| pdf
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| Signature:
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| John C. Yoo
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| EMC2
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| 10/21/2004
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| 10/21/2004
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| Academia
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| University of California
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| pdf
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| Signature:
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| John C. Yoo
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| C2
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| 11/12/2004
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| 11/12/2004
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| Drug Industry
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| Barr Laboratories,
Inc.
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| pdf,
Copyrighted Material
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| Signature:
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| Christine J. Siwik
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| EMC3
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| 12/14/2004
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| 12/14/2004
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| Private Industry
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| Biotechnology Industry
Organization (BIO)
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| pdf
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| Signature:
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| Sara Radcliffe
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| C3
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| 07/13/2005
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| 07/13/2005
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| Private Industry
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| Covington & Burling
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| Table
of Contents
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| Signature:
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| Robert A. Long, Jr.
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| EMC4
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| 07/13/2005
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| 07/13/2005
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| Drug Industry
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| Novartis Pharmaceuticals,
Corp.
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| pdf
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| Signature:
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| Dorothy P. Watson
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| C4
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| 07/21/2005
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| 07/18/2005
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| Drug Industry
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| Novartis Pharmaceuticals,
Corp.
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| pdf
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| Signature:
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| Dorothy P. Watson
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| LET1
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| 05/31/2006
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| 05/31/2006
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| Federal Government
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| FDA/CDER to Biotechnology
Industry Organization (BIO)
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| pdf
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| Signature:
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| Steven K. Galson, M.D., M.P.H.
| |
Top | Up
Page last updated
July 11, 2006
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