FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
 HHS Logo links to Department of Health and Human Services website
Skip navigationFDA Home Page | Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions
horizonal rule

Up | Next | Most Recent

2004N-0018:HUMAN SUBJECT PROTECTION; FOREIGN CLINICAL STUDIES NOT CONDUCTED UNDER AN INVESTIGATIONAL NEW DRUG APPLICATION
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
NPR1   06/09/2004 FDA FDA 06/10/2004 32467-32467 09/08/2004 pdf  
Signature: Jeffrey Shuren
REF1 06/25/2004 06/25/2004 Federal Government
 OMB review for June 10, 2004       pdf, TabA, TabB  
Signature: Amber MacKenzie
EMC1 07/27/2004 07/27/2004 Health Professional R. Pickering, PhD., RN       txt  
Signature: Rexann G. Pickering, PhD., RN
C1 08/23/2004 08/16/2004 Drug Industry Aventis Pharmaceuticals       pdf  
Signature: Steve Caffe, MD
EMC2 08/21/2004 08/21/2004 Health Professional L. Grenade,MD,MPH       txt, Attachment doc, pdf  
Signature: Lois La Grenade,MD,MPH
C2 08/31/2004 08/30/2004 Drug Industry Millennium Pharmaceuticals, Inc. (Millennium)       pdf  
Signature: Robert G. Pietrusko, PharmD
C3 09/02/2004 09/02/2004 Consumer Group Public Citizen       pdf  
Signature: Peter Lurie,MD,MPH and Sidney M. W
EMC3 09/01/2004 09/01/2004 Consumer Group Public Citizen's Health Research Group       txt, Attachment doc, pdf  
Signature: Sidney M. Wolfe, MD
EMC4 09/02/2004 09/02/2004 Health Professional D. Bratt, CMT,MD,MPH          
Signature: David E. Bratt, CMT,MD,MPH
C4 09/08/2004 09/07/2004 Drug Industry AstraZeneca, LP       pdf  
Signature: Gary M. Cooper
C5 09/08/2004 09/08/2004 Drug Industry Pharmaceutical Research and Manufacturers of America (PhRMA)
       pdf  
Signature: Alan Goldhammer, PhD
C6 09/08/2004 09/08/2004 Drug Industry Merck & Co., Inc.       pdf  
Signature: Donald M. Black,MD,MBA
EC1 09/08/2004 09/07/2004 Health Professional Dr. Cynthia Kornegay       htm  
Signature: Kornegay, Cynthia
EC2 09/08/2004 09/08/2004 International Organization
 FLACEIS       htm  
Signature: Feinholz, Dafna
EMC5 09/02/2004 09/02/2004 Health Professional S. Vermund, MD, PhD          
Signature: Sten H. Vermund, MD, PhD
EMC6 09/03/2004 09/03/2004 Individual Consumer R. Candelaria          
Signature: Rey A. Candelaria
EMC7 09/03/2004 09/03/2004 Health Professional R. Newman,MD,MPH          
Signature: Robert G. Newman,MD,MPH
EMC8 09/05/2004 09/05/2004 Health Professional J. Leiss, PhD          
Signature: Jack Leiss, PhD
EMC9 09/07/2004 09/07/2004 Consumer Group Public Citizen's Health Research Group       txt, Attachment doc, pdf  
Signature: Sidney M. Wolfe, MD

Top | Up | Next | Most Recent

Page last updated January 7, 2005 kk

horizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management

[Skip Navigation] link to FDA home page link to U.S. Department of Health and Human Services FDA logo--link to FDA home page