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
Dockets Management

Up

2005N-0285: Current Good Manufacturing Practice Regulation and Investigational New Drugs
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
NPR1   01/12/2006 FDA FDA 01/17/2006 2494-2496 04/03/2006 pdf  
Signature: Jeffrey Shuren
NFR1   01/12/2006 FDA FDA 01/17/2006 2458-2462   pdf  
Signature: Jeffrey Shuren
EMC1 01/17/2006 01/17/2006 Individual Consumer B. Sachau          
EMC2 01/17/2006 01/17/2006 Individual Consumer B. Sachau          
EMC3 01/30/2006 01/30/2006 Individual Consumer A. Ragosta          
C1 02/06/2006 02/01/2006 Academia University of Texas MD Anderson Cancer Center       pdf  
Signature: Lawrence A. Trissel
EC1 02/08/2006 02/07/2006 Federal Government
 Ms. Beth Incao       htm  
 
C2 03/20/2006 03/20/2006 Drug Industry Abbott       pdf  
Signature: Zena Kaufman
EMC4 03/20/2006 03/20/2006 Drug Association Plasma Protein Therapeutics Association (PPTA)       htm
Attachment 		 
Signature: Mary Gustafson
C3 03/27/2006 03/23/2006 Drug Association Plasma Protein Therapeutics Association (PPTA)       pdf  
Signature: Mary Gustafson
C4 03/28/2006 03/28/2006 Private Industry FDA Ready Consulting       pdf  
Signature: Gregory Bobrowicz
C5 03/30/2006 03/29/2006 Association Parenteral Drug Association (PDA)       pdf  
Signature: Robert B. Myers
EC2 04/05/2006 03/02/2006 International Public Citizen
 Mr. Denish Moorthy       htm  
Signature: Moorthy, Denish
EC3 04/05/2006 03/29/2006 Drug Association PDA       pdf  
Signature: Dana, Robert
EC4 04/05/2006 04/03/2006 Private Industry Immel Resources LLC       Attachment, Copyrighted Material  
Signature: Immel, Barbara
EC5 04/05/2006 04/03/2006 Drug Industry Novartis Pharmaceuticals Corp.       Attachment  
Signature: Greene, Kathleen
EC6 04/05/2006 04/03/2006 Consumer Group Public Citizen's Health Research Group       Attachment  
Signature: Wolfe, Sidney
C6 04/03/2006 03/31/2006 Private Industry Cambrex       pdf  
Signature: Barbara B Zinck
C7 04/03/2006 04/03/2006 Private Industry Immel Resource LLC       pdf  
Signature: Barbara Immel
 
C8 04/21/2006 04/20/2006 Drug Industry Bristol-Myers Squibb Company (BMS)       pdf  
Signature: Richard L. Wolgemuth, PhD
NWL1   05/01/2006 FDA FDA 05/02/2006 25747-25747   txt EFF 5/2/06
Signature: Jeffrey Shuren
C9 06/06/2006 05/31/2006 Private Industry Bernstein CMC Regulatory Consulting       pdf  
Signature: David Bernstein, PhD

Top | Up

Page last updated June 14, 2006 kkhorizonal 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