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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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| EC24
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| 04/14/2006
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| 04/04/2006
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| Drug Industry
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| Johnson and Johnson
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| pdf
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| Signature:
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| Rothman, Margaret
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| EC25
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| 04/14/2006
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| 04/04/2006
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| Health Care Association
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| ASCO
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| pdf
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| Signature:
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| Bailes, Joseph
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| EC26
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| 04/14/2006
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| 04/04/2006
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| Other Organization
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| Center for Health
Outcomes Research, UBC
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| pdf
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| Signature:
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| Frank, Lori
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| EC27
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| 04/14/2006
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| 04/04/2006
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| International Organization
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| ISPOR
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| pdf
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| Signature:
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| Dix Smith, Marilyn
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| EC28
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| 04/14/2006
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| 04/04/2006
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| Other Organization
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| Mapi Values
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| pdf
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| Signature:
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| Marquis, Patrick
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| EC29
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| 04/14/2006
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| 04/04/2006
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| Device Industry
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| Boston Scientific
Corporation
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| pdf
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| Signature:
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| Richner, Randel
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| EC30
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| 04/14/2006
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| 04/05/2006
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| Private Industry
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| ClinPhone
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| pdf
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| Signature:
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| Ralston, Jeff
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| EC31
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| 04/14/2006
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| 04/05/2006
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| Drug Industry
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| invivodata, inc
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| pdf
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| Signature:
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| Shiffman, Saul
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| EC32
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| 04/14/2006
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| 04/05/2006
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| Private Industry
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| PRO Consulting
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| pdf
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| Signature:
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| Shields, Alan
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| C11
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| 04/05/2006
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| 04/04/2006
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| Drug Industry
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| Wyeth Pharmaceuticals
Inc
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| pdf
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| Signature:
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| Roy J Baranello
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| C12
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| 04/05/2006
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| 04/04/2006
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| Drug Industry
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| Roche Pharmaceuticals,
Hoffmann-La Roche Inc
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| pdf
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| Signature:
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| Cynthia Dinella PharmD
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| C13
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| 04/07/2006
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| 04/06/2006
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| Drug Industry
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| Bristol-Myers Squibb
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| pdf
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| Signature:
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| Joseph Lamendola PhD
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| C14
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| 04/11/2006
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| 04/11/2006
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| Drug Industry
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| Sanofi-aventis US,
Inc.
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| pdf
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| Signature:
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| Linda F. Bowen
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| C15
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| 04/14/2006
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| 04/13/2006
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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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| Cynthia Dinella, PharmD
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| C16
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| 04/13/2006
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| 04/12/2006
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| Health Care Association
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| Society for Clinical
Data Management, Inc. (SCDM)
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| pdf
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| Signature:
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| David Borbas, R.N., MSN
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| EMC4
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| 04/17/2006
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| 04/17/2006
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| Individual Consumer
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| J. Dean
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| Signature:
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| John Dean
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| EMC5
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| 04/17/2006
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| 04/17/2006
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| Private Industry
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| AmeriFlax
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| pdf
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| Signature:
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| Jan Topp
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| C17
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| 04/20/2006
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| 04/19/2006
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| Private Industry
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| CompleWare Corporation
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| pdf
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| Signature:
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| Kay Weiler, BSN, JD, MA
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| EMC6
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| 08/24/2006
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| 08/24/2006
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| Academia
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| Stony Brook University
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| htm
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| Signature:
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| Arthur A. Stone, PhD
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| Most Recent Page last updated:
April 24, 2007
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