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2005D-0030:
GUIDANCE FOR INDUSTRY ON CLINICAL LACTATION STUDIES STUDY DESIGN,
DATA ANALYSIS, AND RECOMMENDATIONS FOR LABELING
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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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| 02/08/2005
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| 02/08/2005
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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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| 02/07/2005
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| FDA
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| FDA
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| 02/08/2005
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| 6697-6697
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| 04/11/2005
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| pdf
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| Signature:
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| Jeffrey Shuren
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| C1
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| 03/08/2005
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| 03/02/2005
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| Private Industry
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| UCSD Medical Center
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| pdf
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| Signature:
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| Philip O Anderson
PharmD FASHP
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| C2
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| 04/12/2005
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| 04/11/2005
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| Drug Industry
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| Pfizer, Inc.
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| pdf
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| Signature:
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| Melissa S. Tassinari,
PhD, DABT
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| C3
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| 04/12/2005
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| 04/11/2005
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| Drug Industry
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| Bristol-Myers Squibb
Company
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| pdf
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| Signature:
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| Richard L. Wolgemuth,
PhD
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| C4
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| 04/11/2005
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| 04/11/2005
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| Drug Industry
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| Pharmaceutical research and Manufacturers of America (PhRMA)
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| pdf
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| Signature:
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| Alice E. Till, PhD
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| C5
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| 04/07/2005
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| 04/06/2005
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| Federal
Government
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| NIH Clinical Center
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| pdf
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| Signature:
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| Arthur J. Atkinson,
Jr., MD, MACP
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| C6
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| 04/20/2005
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| 04/06/2005
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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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| Paula Long, RN
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| EC1
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| 05/02/2005
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| 04/11/2005
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| Drug Industry
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| Pfizer
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| pdf
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| Signature:
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| Tassinari, Melissa
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| EC2
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| 05/02/2005
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| 04/11/2005
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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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| 04/11/2005
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| Consumer Group
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| Public Citizen's Health
Research Group
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| pdf,
doc
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| Signature:
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| Barbehenn, Elizabeth
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Top
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Page last updated
May 10, 2005
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