2005N-0403:
Requirements for Foreign and Domestic Establishment Registration
and Listing for Human Drugs, Including Drugs that are Regulated
Under a Biologics License Application, and Animal 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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| 08/23/2006
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| FDA
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| FDA
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| 08/29/2006
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| 51276-51357
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| 11/27/2006
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| htm
pdf
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| Signature:
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| Jeffrey Shuren
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| BKG1
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| 08/23/2006
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| 08/23/2006
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| Federal Government
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| Background Material
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| Table
of Contents
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| EMC1
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| 08/29/2006
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| 08/29/2006
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| Individual Consumer
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| J. Benner
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| EMC2
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| 08/31/2006
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| 08/31/2006
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| Individual Consumer
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| P. Carr
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| REF1
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| 09/05/2006
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| 09/05/2006
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| Federal Government
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| OMB Review
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| Part
1
Part 2
Part 3
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| EC1
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| 09/26/2006
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| 09/25/2006
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| Association
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| Compressed Gas Association
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| pdf
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| Signature:
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| Meteyer, Marc
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| EC2
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| 09/27/2006
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| 09/26/2006
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| Drug Association
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| Animal Health Institute
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| pdf
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| Signature:
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| Palla, Madeline
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| C1
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| 10/05/2006
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| 10/03/2006
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| Drug Industry
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| Novartis Pharmaceuticals
Corporation
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| pdf
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| Signature:
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| Soraya Madani, PhD
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| EXT1
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| 10/12/2006
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| 10/12/2006
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| Health Care Association
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| Consumer Healthcare
Products Association (CHPA)
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| pdf
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| Signature:
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| Paul J. Larsen, Esq
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| EXT2
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| 10/16/2006
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| 10/13/2006
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| Drug Industry
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| L. Perrigo Company
(Perrigo)
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| pdf
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| Signature:
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| Heidi Horn
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| NEC1
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| 10/30/2006
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| FDA
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| FDA
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| 10/31/2006
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| 63726-63728
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| 01/26/2007
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| htm
pdf
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| Meeting on 12/11/2006
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| Signature:
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| Jeffrey Shuren
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| C2
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| 11/15/2006
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| 11/07/2006
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| Association
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| Allergen Products
Maufacturers Association
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| pdf
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| Signature:
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| Rebecca R. Johnson, DPh
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| EMC3
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| 11/17/2006
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| 11/16/2006
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| Drug Industry
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| Becton, Dickinson
& Company
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| txt
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| Signature:
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| Jing Zhang
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| C3
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| 11/20/2006
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| 11/20/2006
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| Drug Industry
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| Tap Pharmaceutical
Products, Inc.
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| pdf
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| Signature:
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| Jean M. Conaway, R.Ph., RAC,
MBA
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| C4
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| 11/24/2006
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| 11/24/2006
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| Private Industry
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| GE Health Care
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| pdf
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| Signature:
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| Fred Longenecker
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| EC3
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| 11/27/2006
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| 11/22/2006
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| Drug Industry
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| Ben Venue Laboratories,
Inc.
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| htm
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| Signature:
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| Richesson, C
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| EC4
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| 11/27/2006
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| 11/24/2006
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| Drug Industry
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| Genpharm Inc
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| pdf
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| Signature:
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| Kumar, Salendar
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| EC5
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| 11/27/2006
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| 11/24/2006
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| Drug Association
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| Generic Pharmaceutical
Association
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| htm
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| Signature:
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| Johnston, Gordon
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| EC6
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| 11/27/2006
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| 11/24/2006
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| Drug Industry
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| Taro Pharmaceuticals
USA Inc.
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| htm
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| Signature:
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| Tung, Teresa
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| C5
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| 11/21/2006
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| 11/21/2006
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| Drug Industry
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| TAP Pharmaceutical
Products, Inc.
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| pdf
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| Signature:
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| Jean M. Conaway, R.Ph., RAC,
MBA
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| C6
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| 11/21/2006
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| 11/21/2006
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| Drug Industry
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| Ranbaxy, Inc.
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| pdf
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| Signature:
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| Adina Tortu
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| C7
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| 11/27/2006
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| 11/22/2006
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| Drug Industry
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| Nelco Laboratories,
Inc.
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| pdf
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| Signature:
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| April Catanzaro
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| C8
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| 11/28/2006
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| 11/28/2006
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| Association
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| National Association
of Foreign-Trade Zones
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| pdf
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| Signature:
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| Ray E. Shaw
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| EMC4
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| 11/28/2006
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| 11/27/2006
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| Internationalal Government
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| China
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| txt
pdf
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| Signature:
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| Guo LiSheng
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| EC7
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| 12/01/2006
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| 11/30/2006
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| Private Industry
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| QA
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| htm
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| Signature:
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| LOTTO, FRANCESCA
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| EC8
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| 12/01/2006
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| 11/30/2006
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| Drug Industry
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| Ben Venue Laboratories,
Inc.
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| htm
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| Signature:
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| Benyo, Laurel
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| C9
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| 12/01/2006
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| 12/01/2006
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| Private Industry
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| HollisterStier Laboratories
LLC
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| pdf
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| Signature:
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| David L Mirabell
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| EC9
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| 12/07/2006
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| 12/06/2006
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| Drug Industry
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| Anabolic Laboratories,
Inc.
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| htm
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| Signature:
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| van Osdel, Bob
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| C10
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| 12/11/2006
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| 12/06/2006
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| Health Care Association
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| National Council for
prescription Drug Programs (NCPDP)
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| pdf
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| Signature:
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| Lee Ann C. Stember
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| EC10
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| 12/18/2006
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| 12/15/2006
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| Drug Association
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| NDC Working Group
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| htm
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| Signature:
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| Wallace, Robert
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| EREG1
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| 12/19/2006
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| 12/18/2006
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| Federal Government
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| National Committee
on Vital & Health Statistics
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|
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| pdf
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|
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| Signature:
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| Simon Cohn
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| C11
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| 01/03/2007
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| 01/03/2007
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| Health Care Association
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| Mount Sinai Hospital
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| pdf
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| Signature:
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| Yelena Sinitsyn, MS
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| C12
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| 01/03/2007
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| 12/29/2006
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| Drug Industry
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| Greer Laboratories,
Inc.
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|
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| pdf
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| Signature:
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| Larry Tamura
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| C13
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| 01/08/2007
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| 01/03/2007
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| Drug Industry
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| Roxane Laboratories,
Inc.
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|
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| pdf
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| Signature:
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| Elizabeth Ernst
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| TR1
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| 01/12/2007
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| 01/12/2007
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| Federal Government
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| Transcript of December
11, 2006 Public Meeting
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|
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| pdf
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|
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| TS1
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| 01/12/2007
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| 01/12/2007
|
| Federal Government
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| FDA/CDER
|
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| htm
pdf
ppt
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| FDA's Proposed Revised
21CFR207 Rule and Electronic Drug Registration and Listing
Systems (e-DRLS)
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| Signature:
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| John W Gardner MD DrPH
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| TS2
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| 01/12/2007
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| 01/12/2007
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| Private Industry
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| Hospira Inc
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| htm
pdf
ppt
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| The Proposed Changes
to NDA System, Legacy NDC Numbers and Compliance
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| Signature:
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| Dr Thomas F Willer
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| TS3
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| 01/12/2007
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| 01/12/2007
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| Private Industry
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| Perrigo
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| htm
pdf
ppt
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| Signature:
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| Heidi Horn
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| TS4
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| 01/12/2007
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| 01/12/2007
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| Association
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| CHPA
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| htm
pdf
ppt
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| Signature:
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| Paul J Larsen, Esq.
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| TS5
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| 01/12/2007
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| 01/12/2007
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| Association
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| ICCBBA
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| htm
pdf
ppt
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| Use of ISBT 128 in
the Labeling of Cellular Therapy Products
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| Signature:
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| Pat Distler
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| TS6
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| 01/12/2007
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| 01/12/2007
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| Private Industry
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| AABB`
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| htm
pdf
ppt
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| National Drug Codes
for HCT/Ps
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| Signature:
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| M Allene Carr-Greer, MT ASCP(SBB)
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Page last updated:
February 12, 2007
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