| Up
2005D-0004:
GUIDANCE FOR INDUSTRY ON NONCLINICAL SAFETY EVALUATION OF DRUG COMBINATIONS
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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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| 01/26/2005
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| 01/26/2005
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| Federal
Government
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| Guidance
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| doc,
pdf
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| Signature:
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| Guidance
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| NAD1
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| 01/26/2005
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| FDA
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| FDA
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| 01/26/2005
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| 3714-3715
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| 04/26/2005
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| pdf
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| Signature:
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| SHUREN, JEFFREY
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| EC1
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| 03/23/2005
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| 03/22/2005
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| Drug Industry
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| Alcon Research,
LTD.
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| pdf
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| Signature:
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| Heidel, Garry
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| C1
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| 03/28/2005
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| 03/24/2005
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| Individual Consumer
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| D H McGee PHD
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| C2
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| 04/26/2005
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| 04/25/2005
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| Drug Industry
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| pdf,
02pdf
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| Signature:
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| Michael Garvin,
PharmD
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| C3
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| 04/22/2005
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| 04/21/2005
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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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| Barry Sickels
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| EC2
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| 05/02/2005
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| 04/18/2005
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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
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| EC3
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| 05/02/2005
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| 04/25/2005
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| Drug Industry
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| Eli Lilly and Company
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| Attachment pdf,
doc
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| Signature:
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| van Lier, Robert
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| EC4
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| 05/02/2005
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| 04/25/2005
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| Drug Industry
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| Hoffmann-La Roche,
Inc.
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| pdf
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| Signature:
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| Braen, Angelique
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| EC5
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| 05/02/2005
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| 04/25/2005
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| Drug Industry
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| CANTOX Health Sciences
International
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| pdf
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| Signature:
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| Daniels, Jon
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| EMC1
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| 04/25/2005
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| 04/25/2005
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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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| Douglas L. Sporn
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| EMC2
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| 04/26/2005
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| 04/26/2005
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| Drug Industry
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| Amgen
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| pdf
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| Signature:
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| Jenny Peters
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| EMC3
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| 04/26/2005
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| 04/26/2005
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| Drug Industry
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| Biotechnology Industry
Organization (BIO)
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| pdf,
doc
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| Signature:
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| Sara Radcliffe
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| EMC4
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| 04/26/2005
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| 04/26/2005
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| Drug Industry
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| Merck & Co.,
Inc.
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| pdf,
doc
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| Signature:
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| Brian Mayhew
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Top | Up
Page last updated
May 6, 2005
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