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2004D-0189: Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
GDL1 05/04/2004 05/04/2004 Federal Government
 Guideline       pdf  
Signature: Guideline
NAD1   05/04/2004 FDA FDA 05/05/2004 25130-25132 07/06/2004 pdf  
Signature: SHUREN, JEFFREY
EMC1 05/17/2004 05/17/2004 Individual Consumer T. Scherer          
C1 06/03/2004 05/30/2004 Private Industry Risk Management Resources       pdf  
Signature: Felix M. Arellano, MD
C2 06/29/2004 06/28/2004 Drug Industry Aventis Pharmaceuticals, Inc.       pdf  
Signature: Steve Caffe, MD
EMC2 07/02/2004 07/02/2004 Device Industry Biotechnology Industry Organization (BIO)       pdf  
Signature: Sara Radcliffe
C3 07/07/2004 07/06/2004 Drug Industry Hoffmann-La Roche, Inc. (Roche)       pdf  
Signature: Susan P. Ackermann Shiff, PhD and C
C4 07/07/2004 07/06/2004 Drug Industry Wyeth Pharmaceuticals (Wyeth)       pdf  
Signature: D. Bruce Burlington, M.D.
C5 07/07/2004 07/06/2004 Drug Industry Novartis Pharmaceuticals, Corp. (Novartis)       pdf  
Signature: Judith M. Sills (PharmD)
C6 07/02/2004 07/01/2004 Drug Industry AstraZeneca Pharmaceuticals, LP       pdf  
Signature: Gary Horowitz
C7 07/06/2004 07/06/2004 Drug Industry Pharmaceutical Research and Manufacturers of America (PhRMA)
       pdf  
Signature: Alan Goldhammer, PhD
EMC3 07/06/2004 07/06/2004 Private Industry Centers for Education & research on therapeutics (CERTs)
       pdf  
Signature: Robert M. Califf, MD
EMC4 07/06/2004 07/06/2004 Drug Industry Merck & Co., Inc.       pdf  
Signature: Donald M. Black,MD,MBA
EMC5 07/06/2004 07/06/2004 Drug Industry Johnson and Johnson       pdf, Attachment  
Signature: Janice K. Bush, MD
C8 07/08/2004 07/08/2004 Private Industry ISPE       pdf  
Signature: Annette Stemhagen,DrPH,FISPE
C9 07/12/2004 07/09/2004 Drug Industry Bristol-Myers Squibb Company       pdf  
Signature: Richard L. Wolgemuth, PhD
EC1 06/28/2004 06/28/2004 International Organization
 The Brighton Collaboration       htm, Attachment  
Signature: Kohl, Katrin
EC2 07/03/2004 07/02/2004 Drug Industry Eli Lilly and Company       htm, Attachment  
Signature: Hyslop, David
C10 07/26/2004 07/23/2004 Drug Industry Johnson and Johson Pharmaceutical Research & Development, LLC
       pdf  
Signature: Janice K. Bush, MD

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