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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
EC25 03/02/2007 02/12/2007 Health Care Association College of American Pathologists       pdf  
Signature: Sodeman, MD, Thomas
EC26 03/02/2007 02/16/2007 Health Professional Ms. Mary Barry       htm  
EC27 03/02/2007 02/18/2007 Consumer Group breast cancer advocate, Center for Medical Consume       pdf  
Signature: Schiff, Helen
EC28 03/02/2007 02/22/2007 Academia Baylor University Medical Center       htm  
Signature: Li, Lei
EC29 03/02/2007 02/26/2007 Academia American College of Medical Genetics       pdf  
Signature: Watson, Michael
EC30 03/02/2007 02/26/2007 Device Industry BioSignia, Inc.       pdf  
Signature: Smith, Timothy
EC31 03/02/2007 02/28/2007 Other Organization ASCO       pdf  
Signature: Hortobagyi, Gabriel
EC32 03/02/2007 02/28/2007 Device Industry Invitrogen Corporation       pdf  
Signature: Stavro, Mark
EC33 03/02/2007 03/01/2007 Device Industry Cepheid       pdf  
Signature: Schoonmaker, Michele
C8 03/02/2007 03/02/2007 Private Industry Clinical Laboratory Management Association (CLMA)       pdf  
Signature: Judy Lien
C9 03/05/2007 03/05/2007 Association American Clinical Laboratory Association et al       pdf  
Signature: Alan Mertz
C10 03/05/2007 03/02/2007 Association Coalition for 21st Century Medicine       pdf  
Signature: Joseph Eyer
EC34 03/07/2007 03/02/2007 Health Care Association Association for Molecular Pathology       pdf  
Signature: Williams, Mary Steele
EC35 03/07/2007 03/02/2007 Other Organization Dr. Ken Bloom       pdf  
EC36 03/07/2007 03/02/2007 Academia Johns Hopkins Genetics and Public Policy Center       pdf  
Signature: Javitt, Gail
EC37 03/07/2007 03/02/2007 Consumer Group Mayo Clinic Rochester       htm  
Signature: Cockerill, III, Franklin
EC38 03/07/2007 03/02/2007 Association Coalition for 21st Century Medicine       pdf  
Signature: Eyer, Joseph
EC39 03/07/2007 03/02/2007 Device Association Ventana Medical Systems, Inc.       htm No attachment received
Signature: Tucker, Mark
EC40 03/07/2007 03/02/2007 Device Association Ventana Medical Systems, Inc.       htm No attachment received
Signature: Tucker, Mark
EC41 03/07/2007 03/03/2007 Consumer Group Claire Altman Heine Foundation, Inc.       pdf  
Signature: Heine, Deborah
EC42 03/07/2007 03/05/2007 Private Industry 20/20 GeneSystems, Inc.       pdf  
Signature: Cohen, Jonathan
EC43 03/07/2007 03/05/2007 Device Association Ventana Medical Systems, Inc.       htm No attachment received
Signature: Tucker, Mark
EC44 03/07/2007 03/05/2007 Health Care Association Personalized molecular medicine organizations       pdf  
Signature: Mertz, Alan
EC45 03/07/2007 03/05/2007 Consumer Group Ovarian Cancer National Allliance       pdf  
Signature: Salway Black, Sherry
EC46 03/07/2007 03/05/2007 Health Professional Genomic Health, Inc.       pdf  
Signature: Scott, Randy
EC47 03/07/2007 03/05/2007 Private Industry CardioDx       pdf  
Signature: Levison, David
EC48 03/07/2007 03/05/2007 Association KS       pdf  
Signature: Shelton, Robert
EC49 03/07/2007 03/05/2007 Other Organization Life Sciences Management Group, Inc.       pdf  
Signature: Mackler, Bruce F.
EC50 03/07/2007 03/05/2007 Association Association of American Medical Colleges       pdf  
Signature: Dickler, Howard
EC51 03/07/2007 03/05/2007 Other Organization American Society for Microbiology       pdf  
Signature: Campos, Joseph
EC52 03/07/2007 03/05/2007 Association Parent Project Muscular Dystrophy       htm No attachment received
Signature: Furlong, Patricia
EC53 03/07/2007 03/05/2007 Association Incontinentia Pigmenti International Foundation       pdf  
Signature: Bross Emmerich, Susanne
EC54 03/07/2007 03/05/2007 Association Parent Project Muscular Dystrophy (PPMD)       pdf  
Signature: Furlong, Patricia
EC55 03/07/2007 03/05/2007 Association Trimethylaminuria Foundation       pdf  
Signature: Gordon, Sandy
EC56 03/07/2007 03/05/2007 Device Industry Johnson       pdf  
Signature: Clarke, Dorothy
EC57 03/07/2007 03/05/2007 Private Industry XDx       pdf  
Signature: Wilber, Judith
EC58 03/07/2007 03/05/2007 International Public Citizen University of Cambridge       pdf  
Signature: Hogarth, Stuart
EC59 03/07/2007 03/05/2007 Other Organization National Tay-Sachs       htm  
Signature: Crawford, Kimberly

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Page last updated: March 19, 2007