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2006D-0297: International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
GDL1 08/07/2006 08/07/2006 Federal Government
 Guidance pdf
Signature: Guidance
NAD1 08/07/2006 FDA FDA 08/08/2006 45059-45060 10/10/2006 htm
pdf
Signature: Jeffrey Shuren
EC1 10/05/2006 10/04/2006 Drug Industry Generic Pharmaceutical Association htm
Signature: Johnston, Gordon
C1 10/05/2006 10/04/2006 Drug Industry Abbott pdf
Signature: Scott Messner
EC2 10/06/2006 10/05/2006 Drug Industry Pfizer Inc. htm
Signature: Jacobs, Maria Guazzaroni
EC3 10/10/2006 10/09/2006 Drug Industry Amgen htm
Signature: Peters, Jenny
C2 10/10/2006 10/05/2006 Health Care Association
 Parenteral Drug Association (PDA) Table of Contents
Signature: Robert B. Myers
C3 10/11/2006 10/10/2006 Drug Industry Sanofi-Synthelabo Inc and Aventis Pharmaceuticals
 pdf
Signature: Richard Gural
EC4 10/12/2006 10/10/2006 Drug Association PDA htm
Signature: Dana, Robert
EC5 10/12/2006 10/10/2006 Drug Industry Berlex Inc. htm
Signature: Renfrow, Richard
EMC1 10/11/2006 10/10/2006 Private Industry Merck Research Laboratories/U. S. Regulatory Policy
 pdf CF 2006D-0296/EMC1
Signature: Carolyn Peterson
C4 11/01/2006 10/30/2006 Drug Industry Schering-Plough pdf
Signature: Gretchen Trout

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Page last updated November 22, 2006 kkhorizonal rule
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