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2006D-0044: Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
EMC2 04/04/2006 04/03/2006 Private Industry Amgen       pdf  
Signature: Jenny Peters, J Michael Woolley
EMC3 04/05/2006 04/04/2006 Drug Industry Merck & Col, Inc.       pdf  
Signature: Taryn Rogalski-Salter, PhD
C9 04/03/2006 03/30/2006 International Association
 EORTC, European Organisation for Research and Treatment of Cancer
       pdf  
Signature: Andrew Bottmley, Neil Aaaronson
C10 04/04/2006 03/30/2006 Association International Society for Quality-of-Life Studies       pdf  
Signature: M Joseph Sirgy, PhD
EC9 04/14/2006 04/03/2006 Academia FACIT.org       htm
Attachment 		 
Signature: Cella, David
EC10 04/14/2006 04/03/2006 Academia Evanston Northwestern Healthcare and Northwestern
      htm  
Signature: Cella, David
EC11 04/14/2006 04/04/2006 International Association
 ERIQA Group       pdf  
  Signature: ACQUADRO, Catherine
EC12 04/14/2006 04/04/2006 Drug Association Pharm Res       pdf  
Signature: Goldhammer, Alan
EC13 04/14/2006 04/04/2006 Academia London School of Hygiene       pdf  
Signature: Lamping, Donna
EC14 04/14/2006 04/04/2006 Drug Industry Alcon Research, LTD       htm No attachment received
Signature: Heidel, Garry
EC15 04/14/2006 04/04/2006 Other Organization Galen Research       htm
Attachment 		 
Signature: McKenna, Stephen
EC16 04/14/2006 04/04/2006 Drug Industry Alcon Research, LTD       pdf  
Signature: Heidel, Garry
EC17 04/14/2006 04/04/2006 International Association
 International Society for Quality of Life Research       pdf  
  Signature: Revicki, Dennis
EC18 04/14/2006 04/04/2006 Academia Royal Holloway, University of London       pdf  
Signature: Bradley, Clare
EC19 04/14/2006 04/04/2006 Private Industry QualityMetric Inc.       pdf  
Signature: Bjorner, Jakob
EC20 04/14/2006 04/04/2006 Drug Industry Johnson       pdf  
Signature: Rothman, Margaret
EC21 04/14/2006 04/04/2006 Drug Industry Pfizer       pdf  
Signature: Willke/Perfetto, Richard/Eleanor
EC22 04/14/2006 04/04/2006 Drug Industry CRF Inc.       pdf  
Signature: Gogates, Gregory
EC23 04/14/2006 04/04/2006 Private Industry QualityMetric Inc       pdf  
Signature: Bjorner, Jakob
 

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