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

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Page last updated: April 24, 2007