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2006D-0191: Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
GDL1 05/22/2006 05/22/2006 Federal Government Guidance       pdf  
  Signature: Guidance
NAD1   05/22/2006 FDA FDA 05/23/2006 29651-29652 08/21/2006 txt  
Signature: Jeffrey Shuren
EC1 06/05/2006 05/26/2006 Academia Texas Tech University       htm  
Signature: Westfall, Peter
EC2 06/06/2006 06/05/2006 Health Professional Vanderbilt University School of Medicine       htm  
Signature: Harrell, Frank
C1 06/06/2006 06/06/2006 International London School of Hygiene and Tropical Medicine       pdf  
Signature: Dr. Stuart Pocock
EC3 06/29/2006 06/27/2006 Individual Consumer Dr. Michael Messner       pdf  
EC4 06/29/2006 06/27/2006 Health Professional Johns Hopkins Bloomberg SPH       htm  
Signature: Louis, Thomas
EC5 06/29/2006 06/28/2006 Individual Consumer Dr. ANDREW HARTLEY       pdf  
NM1   06/26/2006 FDA FDA 06/29/2006 37084-37084 08/21/2006 txt  
Signature: Jeffrey Shuren
C2 07/03/2006 06/26/2006 Academia New Jersey Medical School - UMDNJ       pdf  
Signature: Michael Brimacombe, PhD
EC6 08/02/2006 07/31/2006 Drug Industry Alcon Laboratories       htm  
Signature: Von Tress, Mark
EC7 08/02/2006 07/31/2006 Academia Harbor-UCLA Medical Center       pdf  
Signature: Lewis, Roger
LST1 08/14/2006 08/14/2006 Federal Government Agenda for July 27, 2006 Meeting       pdf  
  Signature: Agenda for July 27, 2006 Meeting
TR1 08/14/2006 08/14/2006 Federal Government Transcript of the July 27, 2006 meeting       txt  
  Signature: Transcript of the July 27, 2006 meetin
TS1 08/14/2006 08/14/2006 Federal Government Center for Devices and Radiological Health       pdf An Introduction to the Draft Document: The Use of Bayesian Statistics in the Medical Device Clinical Trials
  Signature: Gregory Campbell, PhD  
TS2 08/14/2006 08/14/2006 Federal Government Center for Devices and Radiological Health       pdf Potential Advantages and Disadvantages to the Bayesian Approach
  Signature: Gerry Gray, PhD  
TS3 08/14/2006 08/14/2006 Federal Government Center for Devices and Radiological Health       pdf Bayesian Statistics: Planning and Analyzing a Flexible Bayesian Clinical Trial
  Signature: Telba Irony, PhD  
TS4 08/14/2006 08/14/2006 Federal Government Center for Devices and Radiological Health       pdf Planning a Bayesian trial: Prior Distributions and Hierarchical Models
  Signature: Gene Pennello, PhD  
TS5 08/14/2006 08/14/2006 Federal Government Center for Devices and Radiological Health       pdf Additional Practical and Computational Issues: Potential Information Requested by FDA
  Signature: Laura Thompson, PhD  
EC8 08/15/2006 08/14/2006 Consumer Group Y-ME National Breast Cancer Organization       htm No attachment received
Signature: Wissmann, Kay
EC9 08/15/2006 08/14/2006 Consumer Group Y-ME National Breast Cancer Organization       htm  
Signature: Wissmann, Kay
EC10 08/16/2006 08/15/2006 Health Professional Lutheran Social Services       htm  
Signature: Morrison, Thomas
EC11 08/18/2006 08/17/2006 Private Industry Cytel Inc.       htm  
Signature: Patel, Nitin
EC12 08/21/2006 08/20/2006 Other Organization Royal Statistical Society       pdf  
Signature: Spiegelhalter, David
EC13 08/22/2006 08/21/2006 Health Care Association Blue Cross and Blue Shield Association       htm  
  Signature: Aronson, Naomi
EC14 08/22/2006 08/21/2006 Device Industry Alquest, Inc.       pdf  
Signature: Lobbestael, Aaron
EC15 08/22/2006 08/21/2006 Academia University of Minnesota       htm  
Signature: Mugglin, Andrew
EC16 08/22/2006 08/21/2006 Private Industry CTRAPS       pdf  
Signature: Engdahl, Karen
M1 08/22/2006 08/22/2006 Federal Government FDA/CBER to DDMB       pdf  
  Signature: Chinying Wang, PhD
C3 08/21/2006 08/18/2006 Drug Industry Abbott Laboratories       pdf  
Signature: April Veoukas, J.D.
C4 08/21/2006 08/21/2006 Drug Industry sanofi-aventis Group       pdf  
Signature: Richard Gural
C5 08/23/2006 08/18/2006 Device Industry Alquest, Inc.       pdf  
Signature: Aaron Lobbestael
C6 08/24/2006 08/22/2006 Private Industry Cook Group Inc. (COOK)       pdf  
Signature: Scott Snyder, PhD
EMC1 08/18/2006 08/18/2006 International Industry Novartis Pharma AG       txt
Attachment		  
  Signature: Dr. Beat Neuenschwander
EMC2 08/21/2006 08/21/2006 Individual Consumer No signature          
EMC3 08/21/2006 08/21/2006 Individual Consumer B. Carlin          
EMC4 08/21/2006 08/21/2006 Individual Consumer J Kadane          
EMC5 08/21/2006 08/21/2006 Individual Consumer H. Lopes          
EMC6 08/21/2006 08/21/2006 Academia S. Goodman, MD, MHS, PhD          
EMC7 08/21/2006 08/21/2006 Individual Consumer Frank          
EMC8 08/23/2006 08/23/2006 Individual Consumer C. Mehta and N. Patel          
EMC9 08/23/2006 08/23/2006 Private Industry Consulants in Toxicology       txt  
Signature: Karen L. Engdahl, B.F.A.
EMC10 08/23/2006 08/23/2006 Drug Industry Blue Cross and Blue Shield Association (BCBSA) Technology Evaluation Center (TEC)       pdf  
Signature: Naomi Aronson, PhD
EMC11 08/23/2006 08/23/2006 Private Industry Statisticians in the Pharmaceutical Industry Limited       txt
Attachment 		 
Signature: Andrew Garrett
SUP1 08/25/2006 08/23/2006 Private Industry Cook Group Inc. (COOK)       pdf  
Signature: Scott Snyder, PhD

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