| Up
2004P-0171:
Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived
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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| 04/08/2004
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| 04/08/2004
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| Drug Industry
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| Genentech, Inc.
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| pdf,
Exhibits: 01,
02, 03,
04
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| Signature:
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| Stephen G. Juelsgaard
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| ACK1
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| 04/09/2004
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| 04/09/2004
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| Federal Government
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| HFA-305 to Genentech,
Inc
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| doc
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| Signature:
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| Jennie Butler
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| EMC1
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| 06/16/2004
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| 06/16/2004
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| Drug Industry
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| Biotechnology Industry
Organization (BIO)
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| pdf
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| Signature:
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| Stephen E. Lawton
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| C1
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| 06/16/2004
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| 06/16/2004
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| Drug Industry
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| Biotechnology Industry
Organization (BIO)
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| pdf
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| Signature:
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| Stephan E. Lawton
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| C2
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| 07/02/2004
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| 07/01/2004
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| Drug Industry
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| Johnson & Johnson
(J&J)
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| pdf
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| Signature:
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| Kathy J. Schroeher
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| C3
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| 08/10/2004
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| 08/10/2004
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| Private Industry
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| California Healthcare
Institute
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| pdf
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| Signature:
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| David L. Gollagher
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| LET1
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| 10/07/2004
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| 10/07/2004
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| Federal Government
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| HFD-005 to Genentech,
Inc.
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| pdf
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| Signature:
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| Jane A. Axelrad
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| C4
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| 10/22/2004
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| 10/22/2004
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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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| doc,
pdf
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| Signature:
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| John C. Yoo
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| C5
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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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| Table
of Contents
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| Signature:
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| Christine J. Siwik
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| C6
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| 11/12/2004
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| 11/12/2004
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| Drug Industry
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| pdf
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| Signature:
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| Bruce N. Kuhlik, Esq and Caroline
J. L
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| EMC3
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| 12/14/2004
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| 12/14/2004
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| Drug 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, MPH
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| RC1
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| 02/23/2005
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| 02/23/2005
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| Drug Industry
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| Genentech, Inc
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| pdf
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| Signature:
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| Stephen G. Juelsgaard
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| EMC4
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| 02/18/2005
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| 02/18/2005
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| Private Industry
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| Genentech Inc
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| pdf
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| Signature:
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| Stephen G Juelsgaard
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| EMC5
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| 04/05/2005
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| 04/05/2005
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| Private Industry
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| Novo Nordisk Inc
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| pdf
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| Signature:
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| James C Shehan
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| C7
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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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| htm
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| Signature:
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| Robert A. Long, Jr.
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| EMC6
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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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| C8
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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,
Corporation
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| pdf
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|
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| Signature:
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| Dorothy P. Watson Shehan
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| LET2
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| 05/31/2006
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| 05/31/2006
|
| Federal Government
|
| FDA/CDER to Genentech,
Inc.
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| pdf
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| Signature:
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| Steven K. Galson, M.D., M.P.H.
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Top | Up
Page last updated
July 11, 2006
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