2007D-0396:
Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Draft
Guidance
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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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| NAD1
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| 10/24/2007
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| FDA
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| FDA
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| 10/25/2007
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| 60681-60682
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| 12/24/2007
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| txt
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| Signature:
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| Jeffrey Shuren
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| GDL1
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| 10/12/2007
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| 10/24/2007
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| Federal Government
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| FDA/CDER/CBER
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| pdf
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| Signature:
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| FDA/CDER/CBER
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| C1
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| 11/13/2007
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| 11/13/2007
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| Private Industry
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| St. Vincent Hospital
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| pdf
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| Signature:
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| Andrew Carr
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| EC1
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| 12/14/2007
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| 12/13/2007
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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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| Dea, Donna
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| C2
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| 12/18/2007
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| 12/18/2007
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| Private Industry
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| Lilly Research Laboratories
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| pdf
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| Guidance generally
supports enrollment of patients with abnormal baseline liver
tests.
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| Signature:
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| Arie Regev, MD
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| C3
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| 12/21/2007
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| 12/21/2007
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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 Sills
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| C4
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| 12/21/2007
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| 12/21/2007
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| Drug Industry
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| Wyeth Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Roy J. Baranello, Jr.
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| C5
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| 12/26/2007
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| 12/26/2007
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| Private Industry
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| Swedich MPA
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| pdf
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| Signature:
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| No signature
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| EC2
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| 12/26/2007
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| 12/17/2007
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| Drug Industry
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| Merck
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| pdf
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| Signature:
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| Ibia, Ekopimo
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| EC3
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| 12/26/2007
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| 12/19/2007
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| Drug Industry
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| GlaxoSmithKline
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| pdf
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| Signature:
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| Stokley, M.S.P.H., Anne N.
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| EC4
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| 12/26/2007
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| 12/19/2007
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| Drug Industry
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| Boehringer Ingelheim
Pharmaceuticals, Inc
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| pdf
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| Signature:
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| Corisco, Christopher
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| EC5
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| 12/26/2007
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| 12/20/2007
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| Drug Industry
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| Sanofi-aventis U.S.
Inc
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| pdf
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| Signature:
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| chaibi, ahlam
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| EC6
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| 12/26/2007
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| 12/22/2007
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| Drug Association
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| Pharm Res
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| pdf
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| Signature:
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| Goldhammer, Alan
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| C6
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| 12/27/2007
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| 12/27/2007
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| Consumer Group
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| Public Citizen Health
Research Group
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| pdf
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| Signature:
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| Elizabeth Barbehenn
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| C7
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| 01/02/2008
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| 01/02/2008
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| Private Industry
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| sanofi aventis
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| pdf
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| Draft Guidance describes
the sensitivity and specificity of various indicators of hepatotoxic
potential.
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| Signature:
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| Mark Moyer
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| C8
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| 01/02/2008
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| 01/02/2008
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| Private Industry
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| Pfizer
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| pdf
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| PremarketingClinical Evaluation, 72 Federal Register, 60681- 60682,
October 25, 2007.
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| Signature:
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| James T. Mayne, Ph.D.
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Page last updated:
January 16, 2008
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