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2006D-0347: Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
NAD1   09/05/2006 FDA FDA 09/07/2006 52800-52801 12/06/2006 txt  
GDL1 09/05/2006 09/05/2006 Federal Government
Guidance       pdf  
EC1 09/22/2006 09/21/2006 Individual Consumer self       htm  
Signature: Ferraro, Phil
EC2 10/05/2006 10/04/2006 Private Industry NHIC - CA Medicare Part B Contractor       htm  
Signature: Quinn, Bruce
EC3 10/06/2006 10/05/2006 Private Industry InterGenetics Incorporated       htm  
Signature: Shimasaki, Craig
EC4 10/10/2006 10/06/2006 Association Genetic Alliance       htm  
Signature: Malkoc, Orkideh
EC5 10/18/2006 10/13/2006 Device Industry GHC Technologies, Inc.       htm  
Signature: Stoughton, Roland
EC6 10/25/2006 10/20/2006 Health Professional Dr. Jon Rosenblatt       htm  
EC7 11/03/2006 11/02/2006 Academia Genetics and Public Policy Center       htm
Signature: Hudson, Kathy
EC8 11/14/2006 11/13/2006 Device Industry Prediction Sciences htm
Signature: Linke, Steven
EC9 11/21/2006 11/20/2006 Health Professional Genomic Health, Inc. htm
Signature: Scott, Randy
EC10 11/21/2006 11/20/2006 International Organization
Public Health Genetics Unit htm
Signature: Zimmern, Ronald
EXT1 11/21/2006 11/20/2006 Drug Industry Aureon Laboratories, Inc. pdf
Signature: Vijay Aggarwal, PhD
C1 11/21/2006 11/16/2006 Health Care Association
Mayo Clinical Trial Services pdf
Signature: Lawrence K. Oliver, PhD
EC11 11/27/2006 11/26/2006 Health Professional M. D. Anderson Cancer Center htm
Signature: Grossman, H. Barton
NEC1 11/27/2006 FDA FDA 11/28/2006 68822-68823 03/05/2007 txt
C2 12/05/2006 12/04/2006 Private Industry Insilicos LLC pdf
Signature: Erik Nilsson
EC12 12/07/2006 12/06/2006 Drug Industry Eli Lilly and Company htm
Signature: Allison, Christine
NM1 01/08/2007 FDA FDA 01/09/2007 967-968 03/05/2007 txt
Signature: Jeffrey Shuren
EC13 01/19/2007 01/18/2007 Consumer Group Research Advocacy Network htm
Signature: Railey, Elda
EC14 01/31/2007 01/30/2007 Health Professional McDermott, Will       pdf  
Signature: Radensky, Paul
EC15 02/12/2007 02/01/2007 Device Industry Exagen Diagnostics, Inc.       pdf  
Signature: Popper, Caroline
EC16 02/12/2007 02/01/2007 Academia Baylor College of Medicine - Dept of Genetics       pdf  
Signature: Beaudet, Arthur
EC17 02/12/2007 02/01/2007 Association Ovarian Cancer National Alliance       pdf  
Signature: Salway-Black, Sherry
EC18 02/12/2007 02/01/2007 Health Care Association association of american physician and surgeons       pdf  
  Signature: ostrolenk, michael
TS1 02/02/2007 02/02/2007 Academia Baylor College of Medicine       Letter, Presentation (pdf) (ppt) (htm)  
Signature: R Joel Slomoff, Dr Arthur Beaudet
TS2 02/07/2007 02/02/2007 Academia Genetics and Public Policy Center, Johns Hopkins University       pdf  
Signature: Gail Javitt JD MPH
C3 02/13/2007 02/08/2007 Association BlueCross BlueShield Association       pdf  
Signature: Allan M Korn MD FACP
EC19 02/22/2007 02/01/2007 Health Care Association Association for Molecular Pathology       htm  
  Signature: Williams, Mary Steele
EC20 02/22/2007 02/01/2007 Health Care Association American Clinical Laboratory Association       pdf  
  Signature: Mertz, Alan
EC21 02/22/2007 02/01/2007 Device Industry Exagen Diagnostics, Inc.       pdf  
Signature: Popper, Caroline
EC22 02/22/2007 02/01/2007 Drug Industry Genzyme Genetics       pdf  
Signature: Aspinall, Mara
EC23 02/22/2007 02/01/2007 Private Industry Mr. David Levison       pdf  
EC24 02/22/2007 02/01/2007 Device Industry Mr. Jonathan Cohen       htm  
C4 02/13/2007 02/12/2007 Association College of American Pathologists       pdf  
Signature: Thomas Sodeman MD
C5 02/16/2007 02/13/2007 Association American Association for Clinical Chemistry (AACC)       pdf  
Signature: Larry Broussard PhD
C6 03/01/2007 02/28/2007 Association American Clinical Laboratory Association       pdf  
Signature: Alan Mertz
C7 02/28/2007 02/23/2007 Individual Consumer H. Schiff          

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Page last updated: March 14, 2007