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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
EC60 03/07/2007 03/05/2007 Private Industry Target Discovery, Inc.       pdf  
Signature: Peterson, Jeff
EC61 03/07/2007 03/05/2007 Association National Tay-Sachs       pdf  
Signature: Crawford, Kim
EC62 03/07/2007 03/05/2007 Consumer Group National Breast Cancer Coalition Fund       pdf  
Signature: Hinestrosa, Carolina
EC63 03/07/2007 03/05/2007 Private Industry Genzyme Corp.       pdf  
Signature: Yocher, Robert
EC64 03/07/2007 03/05/2007 Device Association Advanced Medical Technology Association       pdf  
Signature: Jones, Carolyn
EC65 03/07/2007 03/05/2007 Consumer Group Genetic Alliance       pdf  
Signature: Terry, Sharon
EC66 03/07/2007 03/05/2007 Device Industry Ciphergen Biosystems, Inc.       pdf  
Signature: Page, Gail
EC67 03/07/2007 03/05/2007 Device Industry Ciphergen Biosystems, Inc.       pdf  
Signature: Page, Gail
EC68 03/07/2007 03/05/2007 Private Industry Target Discovery, Inc.       pdf  
Signature: Peterson, Jeff
EC69 03/07/2007 03/05/2007 Consumer Group Washington Legal Foundation       pdf  
Signature: Samp, Richard
C11 03/08/2007 03/06/2007 Private Industry Save Babies Through Screening       pdf  
Signature: Jill Levy-Fisch
C12 03/09/2007 03/05/2007 Private Industry KS&A       pdf  
Signature: Robert H Shelton
C13 03/09/2007 03/08/2007 Drug Industry Pfizer Inc       pdf  
Signature: Emily Marden
C14 03/13/2007 03/08/2007 Private Industry XDx Inc pdf
Signature: Judith C Wilber PhD, D(ABMM)
C15 03/23/2007 03/21/2007 Private Industry Hoffmann-La Roche (Roche) pdf
Signature: M.J. Finley Austin, and Michael Samo
EC70 04/03/2007 02/02/2007 Consumer Group Personalized Medicine Coalition pdf
Signature: Abrahams, Edward
EC71 04/03/2007 02/02/2007 Association Advanced Medical Technology Association htm
Signature: Jones, Carolyn
EC72 04/03/2007 02/02/2007 Academia Johns Hopkins Genetics and Public Policy Center htm
Signature: Javitt, Gail
EC73 04/03/2007 02/02/2007 Consumer Group National Breast Cancer Coalition Fund htm
Signature: Hinestrosa, M. Carolina
EC74 04/03/2007 02/02/2007 Consumer Group Research Advocacy Network htm
Signature: Railey, Elda
EC75 04/03/2007 02/05/2007 Private Industry AviaraDx htm
Signature: Berry, Carol
EC76 04/03/2007 02/05/2007 Consumer Group Marti Nelson Cancer Foundation htm
Signature: Erwin, Robert
EC77 04/03/2007 02/05/2007 Health Care Association
Association for Molecular Pathology (AMP) htm
Signature: Williams, Mary Steele
EC78 04/03/2007 02/07/2007 Device Association Advanced Medical Technology Association htm
Signature: Jones, Carolyn
EC79 04/03/2007 02/21/2007 Association Coalition for 21st Century Medicine htm
Signature: Tsakeris, Thomas
EC80 04/03/2007 02/26/2007 Private Industry Mohr Davidow Ventures htm
Signature: Goldberg, Michael
EC81 04/03/2007 03/02/2007 Drug Industry Genentech, Inc. htm No attachment received
Signature: Beakes-Read, Virginia
EC82 04/03/2007 03/02/2007 Device Association Ventana Medical Systems, Inc. htm No attachmetn received
Signature: Tucker, Mark
EC83 04/03/2007 03/02/2007 Drug Industry Genentech, Inc. htm
Signature: Beakes-Read, Virginia
EC84 04/03/2007 03/04/2007 Health Care Association
American Society for Clinical Laboratory Science htm
Signature: Passiment, Elissa
EC85 04/03/2007 03/05/2007 Private Industry Mohr Davidow Ventures htm
Signature: Goldberg, Michael
EC86 04/03/2007 03/03/2007 Consumer Group Claire Altman Heine Foundation, Inc. htm
Signature: Heine, Deborah
EC87 04/03/2007 03/05/2007 Device Industry Johnson htm
Signature: Clarke, Dorothy
C16 04/05/2007 04/05/2007 Private Industry Baylor College of Medicine pdf
Signature: R Joel Slomoff
TR1 03/01/2007 03/01/2007 Federal Government
Transcript of the 2/8/07 Public Meeting

01.pdf

02.pdf

03.pdf

,
Signature: Transcript of the 2/8/07 Public Meetin
MM1 05/29/2007 05/29/2007 Federal Government
FDA and 21st Century Medicine Coalition pdf
Signature: Kristi Moran
C17 04/23/2007 04/23/2007 Association American Clinical Laboratory Association (ACLA) pdf
Signature: Alan Mertz
EMC1 06/11/2007 06/11/2007 Private Industry ASCO pdf
Signature: Cynthia Stephens, R. A. C.
NAD2 07/23/2007 FDA FDA 07/26/2007 41081-41083 08/27/2007 pdf
Signature: SHUREN, JEFFREY
GDL2 07/23/2007 07/23/2007 Federal Government
Guidance pdf
Signature: Guidance
EXT2 07/31/2007 07/30/2007 Device Industry 21st Century Medicine pdf
Signature: Joseph Eyer
EXT3 08/02/2007 07/31/2007 Private Industry NANOGEN, Inc pdf
Signature: Howard C. Birndorf
LET1 08/03/2007 08/03/2007 Federal Government
FDA to Personalized Medicine Coalition pdf
Signature: Jeffrey Shuren
EC88 08/03/2007 08/02/2007 Device Industry Longwell and Associates htm
Signature: Longwell, Anna

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Page last updated: August 6, 2007