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2005D-0286: Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
GDL1 01/17/2006 01/17/2006 Federal Government
 Guidance       pdf  
NAD1   01/17/2006 FDA FDA 01/17/2006 2552-2554 03/20/2006 txt  
Signature: Jeffrey Shruen
EMC1 02/08/2006 02/08/2006 Individual Consumer B. Sachau          
C1 03/07/2006 02/27/2006 Private Industry Elemental Research, Inc.       pdf  
Signature: Mercedes Stuart
C2 03/14/2006 03/10/2006 Drug Industry Pharmaceutical Research and Manufacturers of America (PhRMA)
       pdf  
Signature: Alice E. Till, PhD
C3 03/20/2006 03/17/2006 Drug Industry Cambrex Corporation       pdf  
Signature: Barbara B. Zinck
C4 03/16/2006 03/14/2006 Drug Industry Novartis Pharmaceuticals       pdf  
Signature: Kathleen Greene
C5 03/16/2006 03/15/2006 Drug Industry Amgen       pdf  
Signature: Barbara W. Unger
C6 03/16/2006 03/15/2006 Health Care Association
 GE HEalthcare       pdf  
  Signature: Fred Longenecker
C7 03/20/2006 03/17/2006 Drug Industry Chiron Corporation       pdf  
Signature: Gia D. DePillis, PhD
C8 03/20/2006 03/17/2006 Drug Association Parenteral Drug Association (PDA)       pdf  
Signature: Richard V. Levy, PhD
C9 03/20/2006 03/17/2006 Drug Industry Abbott       pdf  
Signature: Zena Kaufman
C10 03/21/2006 03/20/2006 Drug Industry Wyeth Pharmaceuticals, Inc.       pdf  
Signature: Roy J. Baranello
EMC2 03/20/2006 03/20/2006 International Industry
 Japan Society of Pharmaceutical Machinery and Engineering (JSPME)
       pdf
Attachment 		 
Signature: Katsuhide Terada, PhD
EMC3 03/21/2006 03/21/2006 Drug Industry Biotechnology Industry Organization (BIO)       pdf  
Signature: Sara Radcliffe
C11 03/29/2006 03/20/2006 International Industry
 Japan Society of Pharmaceutical Machinery and Engineering (JSPME)
       pdf  
  Signature: KAtsuhide Terada, PhD
C12 03/30/2006 03/27/2006 Drug Industry Schering-Plough       pdf  
Signature: Gretchen Trout
C13 04/18/2006 04/13/2006 Device Association International Society for Pharmaceutical Engineering (ISPE)
       pdf  
Signature: Robert P. Best
 
C14 04/21/2006 04/20/2006 Drug Industry Bristol-Myers Squibb Company (BMS)       pdf  
Signature: Richard L. Wolgemuth, PhD
EC1 04/26/2006 03/13/2006 Drug Industry Novartis Pharmaceutical Corp.       pdf
Attachment 		 
Signature: Greene, Kathleen
EC2 05/01/2006 03/20/2006 Drug Industry AstraZeneca       pdf  
Signature: Damstetter , Philip
EC3 05/01/2006 03/20/2006 Drug Association PDA       htm  
Signature: Dana, Robert
EC4 05/01/2006 03/20/2006 Health Professional LearningPlus       pdf  
Signature: Vesper, James
EC5 05/01/2006 03/20/2006 Drug Industry Takeda Global Research and Development Center, Inc
       pdf  
Signature: Rojewski, Chris
EC6 05/01/2006 03/20/2006 Drug Industry Schering-Plough       pdf  
Signature: Crew, Jacqueline
EC7 05/01/2006 03/20/2006 Drug Industry Johnson       pdf  
Signature: Kowtna, Christopher
EC8 05/01/2006 03/20/2006 Drug Industry Sanofi Pasteur       pdf  
Signature: Guito, Ken
EC9 05/01/2006 03/21/2006 Private Industry Immel Resources LLC       pdf
Att 1, Att 2 		 
Signature: Immel, Barbara

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