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2005D-0062:
Draft Guidance FDAs Drug Watch for Emerging Drug Safety
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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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| 05/10/2005
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| 05/09/2005
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| Federal
Government
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| Guidance
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| pdf
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| Signature:
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| Guidance
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| NAD1
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| 05/09/2005
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| FDA
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| FDA
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| 05/10/2005
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| 24606-24607
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| 08/08/2005
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| pdf
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| Signature:
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| Jeffrey Shuren
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| EC1
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| 05/26/2005
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| 05/11/2005
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| Media
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| Pharma Marketing News
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| pdf
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| Signature:
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| Mack, John
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| EMC1
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| 05/22/2005
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| 05/22/2005
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| Individual Consumer
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| B. Sachau
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| EC2
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| 06/17/2005
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| 06/13/2005
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| Health Care Association
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| National Organization
for Rare Disorders (NORD)
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| pdf
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| Signature:
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| Meyers, Abbey
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| EC3
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| 06/17/2005
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| 06/13/2005
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| Health Care
Association
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| National Organization
for Rare Disorders (NORD)
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| pdf
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| Signature:
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| Meyers, Abbey
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| EC4
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| 06/17/2005
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| 06/13/2005
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| Health Care
Association
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| National Organization
for Rare Disorders (NORD)
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| pdf
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| Signature:
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| Meyers, Abbey
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| C1
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| 06/17/2005
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| 06/14/2005
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| Association
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| National Organization
for Rare Disorders Inc
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| pdf
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| Signature:
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| Abbey S Meyers
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| C2
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| 06/17/2005
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| 06/15/2005
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| Drug Industry
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| Ovation Pharmaceuticals
Inc
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| pdf
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| Signature:
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| Kathryn B Patterson
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| C3
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| 07/25/2005
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| 07/21/2005
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| Drug Industry
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| Wyeth Pharmaceuticals
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| pdf
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| Signature:
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| Roy J. Baranello, Jr.
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| C4
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| 08/01/2005
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| 07/29/2005
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| Association
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| Society for Women's
Health Research
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| pdf
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| Signature:
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| Phyllis Greenberger, Martha
Nolan
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| C5
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| 08/02/2005
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| 08/01/2005
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| Drug Industry
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| AstraZeneca LP
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| pdf
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| Signature:
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| Anthony F Rogers
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| C6
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| 08/05/2005
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| 08/04/2005
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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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| Judith M. Sills, PharmD
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| C7
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| 08/08/2005
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| 08/08/2005
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| Drug Industry
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| GlaxoSmithKline (GSK)
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| pdf
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| Signature:
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| Edward N. Pattishall,MD,MPH
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| C8
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| 08/08/2005
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| 08/05/2005
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| Drug Industry
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| Eli Lilly and Company
(Lilly)
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| pdf
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| Signature:
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| Timothy R. Franson, M.D.
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| C9
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| 08/08/2005
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| 08/08/2005
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| Drug Industry
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| National
Council on Patient Information and Education (NCPIE)
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| pdf
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| Signature:
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| William Ray Bullman
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| C10
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| 08/08/2005
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| 08/08/2005
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| Drug Industry
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| Abbott Laboratories
(Abbott)
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| pdf
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| Signature:
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| Douglas L. Sporn
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| C11
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| 08/08/2005
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| 08/05/2005
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| Drug Industry
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| Genentech
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| pdf
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| Signature:
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| Robert L. Garnick, PhD
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| C12
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| 08/08/2005
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| 08/08/2005
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| Association
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| American Society of
Clinical Oncology (ASCO)
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| pdf
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| Signature:
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| Sandra J. Horning, MD
| |
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