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2006D-0044:
Guidance for Industry on Patient-Reported Outcome Measures: Use
in Medical Product Development to Support Labeling Claims
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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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| 02/02/2006
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| 02/15/2006
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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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| 02/02/2006
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| FDA
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| FDA
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| 02/03/2006
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| 5862-5863
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| 04/04/2006
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| txt
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| Signature:
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| SHUREN, JEFFREY
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| C1
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| 02/22/2006
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| 02/21/2006
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| Academia
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| Institute of Health
Economics
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| pdf
Attachments
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| Signature:
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| David Feeny, PhD et al.
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| C2
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| 04/04/2006
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| 04/04/2006
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| Device Association
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| Advanced Medical Technology
Association (AdvaMed)
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| pdf
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| Signature:
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| Tara Federici
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| C3
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| 04/04/2006
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| 04/04/2006
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| Private Industry
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| etrials, Inc.
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| pdf
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| Signature:
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| Richard Piazza, PharmD
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| C4
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| 04/04/2006
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| 04/03/2006
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| Private Industry
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| UCB, Inc.
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| pdf
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| Signature:
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| Robert A. Paarlberg
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| C5
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| 04/04/2006
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| 04/03/2006
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| Device Association
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| Healthcare Technology
Systems
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| pdf
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| Signature:
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| Robert A. Paarlberg
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| C6
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| 04/04/2006
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| 04/03/2006
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| Drug Industry
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| Genentech
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| pdf
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| Signature:
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| Robert L. Garnick, PhD
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| EC1
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| 04/07/2006
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| 02/27/2006
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| Health Professional
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| M. D. Anderson Cancer
Center
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| htm
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| Signature:
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| Meyers, Christina
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| EC2
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| 04/07/2006
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| 03/15/2006
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| Academia
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| EMGO Institute, VU
University Medical Center
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| DOC
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| Signature:
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| Terwee, Caroline
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| EC3
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| 04/07/2006
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| 03/17/2006
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| Federal Government
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| NIH
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| htm
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| Signature:
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| Riley, William
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| EC4
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| 04/07/2006
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| 03/28/2006
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| Health Professional
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| Capitol Outcomes Research,
Inc.
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| htm
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| Signature:
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| Meyerhoff, Allen
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| EC5
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| 04/07/2006
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| 03/30/2006
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| International Organization
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| EORTC Data Center
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| pdf
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| Signature:
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| Bottomley, Andrew
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| EC6
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| 04/07/2006
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| 03/31/2006
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| Drug Industry
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| Eli Lilly and Company
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| pdf
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| Signature:
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| Melfi, Catherine
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| EC7
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| 04/07/2006
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| 03/31/2006
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| Academia
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| Stanford University
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| Signature:
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| Fries, James
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| EC8
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| 04/07/2006
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| 04/03/2006
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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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| C7
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| 04/10/2006
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| 03/31/2006
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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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| Dr. James Fries
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| C8
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| 04/10/2006
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| 03/30/2006
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| Drug Industry
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| AstraZeneca Pharmaceuticals,
LP
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| pdf
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| Signature:
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| Debra N. Shiozawa, PhD
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| EMC1
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| 03/31/2006
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| 03/31/2006
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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 R Sporn
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January 8, 2007
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