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Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Draft
Guidance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