| Up
2005D-0310:
Guidance for Industry on Gene Therapy Clinical Trials Observing
Participants for Delayed Adverse Events
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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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| 08/23/2005
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| 08/23/2005
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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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| 08/22/2005
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| FDA
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| FDA
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| 08/23/2005
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| 49296-49297
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| 11/21/2005
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| pdf
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| Signature:
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| Jeffrey Shuren
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| BKG1
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| 08/23/2005
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| 08/23/2005
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| Federal
Government
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| Background Material
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| Table
of Contents
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| Signature:
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| Background Material
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| EC1
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| 10/13/2005
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| 10/07/2005
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| Academia
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| Hannover Medical School
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| htm
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| Signature:
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| Baum, Christopher
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| C1
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| 10/21/2005
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| 10/20/2005
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| Academia
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| Stanford University
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| pdf
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| Signature:
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| Ellyn Segal, PhD
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| C2
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| 11/21/2005
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| 11/21/2005
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| Drug Industry
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| Sanofi-Synthelabo, Inc. and Aventis Pharmaceuticals
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| pdf
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| Signature:
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| Steve Caffe, M.D.
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| C3
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| 11/22/2005
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| 11/21/2005
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| Drug Industry
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| Cell Genesys, Inc.
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| pdf
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| Signature:
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| Carol C. Grundfest
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| EC2
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| 11/25/2005
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| 11/21/2005
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| Other Organization
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| Biotechnology Industry
Organization
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| Attachment
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| Signature:
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| Oldham, Jessica
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| EC3
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| 11/25/2005
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| 11/21/2005
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| Drug Industry
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| Merck
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| Attachment
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| Signature:
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| Rogalski-Salter, Taryn
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| EC4
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| 11/25/2005
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| 11/21/2005
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| Private Industry
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| Schering Plough Corporation
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| Attachment
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| Signature:
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| Trout, Gretchen
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| EC5
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| 11/25/2005
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| 11/21/2005
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| Drug Industry
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| Targeted Genetics
Corporation
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| Attachment
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| Signature:
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| Saltzstein, Rae
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| EMC1
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| 11/21/2005
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| 11/21/2005
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| Association
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| Biotechnology Industry
Organization
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| pdf
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| Signature:
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| Sara Radcliffe
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| EXT1
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| 11/21/2005
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| 11/21/2005
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| Private Industry
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| International Center
for Technology Assessment
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| pdf
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| Signature:
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| Sara Radcliffe
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| EMC2
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| 11/22/2005
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| 11/21/2005
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| Private Industry
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| Cell Genesys Inc
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| pdf
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| Signature:
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| Carol C Grundfest
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| EMC3
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| 11/23/2005
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| 11/23/2005
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| International
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| European Medicines
Agency (EMEA)
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| 02.pdf
, 03.pdf
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| Signature:
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| Dr. Daniel Brasseur
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| EMC4
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| 11/28/2005
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| 11/28/2005
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| Drug Industry
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| Targeted Genetics
Coporation (TGC)
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| pdf
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| Signature:
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| Rae Saltzstein
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Top | Up
Page last updated
December 28, 2005
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