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2006D-0088: Guidance for Industry; Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
GDL1 03/09/2006 03/09/2006 Federal Government
GUIDANCE       pdf  
  Signature: GUIDANCE
NAD1   03/09/2006 FDA FDA 03/10/2006 12366-12367 06/08/2006 txt  
Signature: Jeffrey Shuren
BKG1 03/10/2006 03/10/2006 Federal Government
Background Material       Table of Contents  
  Signature: Background Material
EC1 05/08/2006 04/11/2006 Health Professional Campbell University School of Pharmacy       htm  
Signature: Johnson, Mary
EC2 05/08/2006 04/24/2006 Individual Consumer Mr. Dave Lowe       htm
Attachment
 
C1 06/01/2006 05/25/2006 Private Industry PowderMed 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
EC3 06/06/2006 05/25/2006 Drug Industry PowderMed Ltd.       pdf  
Signature: Gannaway, David
C3 06/06/2006 06/06/2006 Federal Government National Institutes of Health (NIH)       pdf  
  Signature: Kanta Subbarao, MD, MPH et al.
C4 06/07/2006 06/06/2006 Drug Industry Solvay Pharmaceuticals, Inc.       Table of Contents  
Signature: Michael F. Hare
EC4 06/13/2006 06/06/2006 Drug Industry MedImmune       pdf  
Signature: Kavanaugh, Nancy
EC5 06/13/2006 06/07/2006 Drug Industry GlaxoSmithKline       pdf  
Signature: Stokley, M.S.P.H., Anne N.
EC6 06/13/2006 06/08/2006 Health Care Association Infectious Diseases Society of America       pdf  
  Signature: Hantman, Julie
EC7 06/13/2006 06/08/2006 Drug Industry Sanofi Pasteur       pdf  
Signature: Guito, Ken
EMC1 06/23/2006 06/23/2006 Federal Government NIAID       pdf  
  Signature: Ranjan Gupta, PhD

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