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2006D-0083: Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
GDL1 03/09/2006 03/17/2006 Federal Government
GUIDANCE       pdf  
Signature: GUIDANCE
NAD1   03/09/2006 FDA FDA 03/10/2006 12367-12367 06/08/2006 txt  
Signature: Jeffrey Shuren
BKG1 04/10/2006 03/10/2006 Federal Government
Background Material       Table of Contents  
Signature: Background Material
EC1 05/09/2006 04/13/2006 Health Professional Campbell University       htm  
Signature: Bone, Sara
Signature: Bone, Sara
C1 06/01/2006 05/25/2006 Animal Feed Industry
PowerMed Ltd       pdf  
Signature: David J. Gannaway, PhD
C2 06/05/2006 06/02/2006 Drug Industry Novartis Vaccines       pdf  
Signature: Maurice W. Harmon, PhD., RAC
EC2 06/06/2006 05/25/2006 Drug Industry PowderMed      

pdf , Copyrighted Material

 
Signature: Gannaway, David
C3 06/07/2006 06/06/2006 Drug Industry Solvay Pharmaceuticals, Inc.       pdf  
Signature: Michael F. Hare
C4 06/12/2006 06/09/2006 Drug Industry Sanofi Pasteur, Inc       pdf  
Signature: Kenneth P. Guito

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Page last updated: January 8, 2007