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2003D-0380:DRAFT
GUIDANCE FOR INDUSTRY: PAT - A FRAMEWORK FOR INNOVATIVE PHARMACEUTICAL
MANUFACTURING AND QUALITY ASSURANCE; AVAILABILITY
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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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| GDL1
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| 09/04/2003
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| 09/04/2003
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| Federal
Government
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| Draft Guidance
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| pdf,
doc
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| Signature:
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| Draft Guidance
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| NAD1
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| 09/04/2003
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| FDA
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| FDA
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| 09/05/2003
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| 52781-52782
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| 11/05/2003
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| EMC1
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| 10/21/2003
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| 10/21/2003
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| International Industry
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| Novo Nordisk
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| txt,
Attachment
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| Signature:
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| Dr. Jan Gustafsson
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| C1
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| 10/28/2003
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| 10/27/2003
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| International Industry
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| Merck KGaA
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| pdf
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| Signature:
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| Dr. Oelrich &
Dr. Buttgenbach
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| C2
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| 10/28/2003
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| 10/27/2003
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| Drug Industry
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| Purdue Pharma, LP
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| pdf
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| Signature:
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| Suzett L. Perry
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| C3
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| 10/29/2003
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| 10/28/2003
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| Drug Industry
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| AstraZeneca Pharmaceuticals,
LP
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| pdf
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| Signature:
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| Louis E. Kovach
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| C4
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| 10/29/2003
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| 10/29/2003
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| Private Industry
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| Umetrics, Inc.
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| pdf
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| Signature:
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| Svante Wold
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| C5
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| 10/31/2003
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| 10/30/2003
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| Drug Industry
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| Abbott Laboratories
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| pdf
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| Signature:
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| Richard Poska, R.Ph
& Richard M. Joh
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| C6
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| 10/30/2003
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| 10/28/2003
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| Drug Industry
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| Cambrex Corporation
(Cambrex)
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| pdf
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| Signature:
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| Barbara B. Zinck
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| EMC2
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| 10/30/2003
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| 10/30/2003
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| Health Professional
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| Facility
Automation Management Engineering Systems
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| pdf
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| Signature:
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| Dr. Paul King
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| EMC3
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| 10/30/2003
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| 10/30/2003
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| International Industry
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| H. Lundbeck A/S
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| text,
Attachments: pdf1,
pdf2
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| Signature:
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| Line Lundsberg-Nielson
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| EMC4
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| 10/30/2003
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| 10/30/2003
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| Drug Industry
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| Eli Lilly and Company
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| txt,
Attachment
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| Signature:
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| Tobias Massa, PhD
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| EMC5
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| 10/31/2003
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| 10/31/2003
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| Drug Industry
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| Pfizer, Inc.
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| txt,
Attachment
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| Signature:
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| Sonja Sekulic, PhD
& Randall Schadt
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| EMC6
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| 11/03/2003
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| 11/03/2003
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| Drug Industry
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| GlaxoSmithKline
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| txt
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| Signature:
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| Mary Faye S. Whisler,
PhD
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| C7
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| 11/03/2003
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| 11/03/2003
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| Drug Industry
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| Pfizer, Inc.
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| pdf
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| Signature:
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| Sonja Sekulic, PhD
& Randall Schadt
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| C8
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| 11/04/2003
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| 11/03/2003
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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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| Alice E. TIll, PhD
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| C9
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| 11/06/2003
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| 10/31/2003
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| International Industry
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| Japan Society
of Pharmaceutical Machinery and Engineering
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| pdf
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| Signature:
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| Katsuhide Terada,
PhD
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| C10
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| 11/04/2003
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| 11/04/2003
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| Drug Industry
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| Novartis Pharmaceuticals
Corp. (Novartis)
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| pdf
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| Signature:
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| Joan A. Materna
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| Most Recenter
Page last updated
January 6, 2005
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