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-0262: Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
N1   07/13/2005 FDA FDA 07/14/2005 40719-40720 12/31/2006 pdf  
Signature: JEFFREY SHUREN
EC1 07/20/2005 07/19/2005 Drug Industry Merck       Confidential - Pilot Program Request
Signature: Tway, Patricia C.
EC2 07/20/2005 07/19/2005 Private Industry Dr. Nicholas Fleischer       htm  
LET1 07/25/2005 07/22/2005 Drug Industry Pfizer, Inc.       Confidential - Pilot Program Request
Signature: Roger Nosal
EC3 07/29/2005 07/28/2005 Drug Association none       htm  
EC4 08/05/2005 08/04/2005 Individual Consumer Mr. paul bavaro       htm  
LET2 08/12/2005 08/11/2005 Drug Industry Wyeth Pharmaceuticals       Confidential - Pilot Program Request
Signature: Patricia Foti Mann
EC5 08/15/2005 08/13/2005 Drug Industry Ms. Laura Latt       htm  
EC6 08/16/2005 08/15/2005 Drug Industry PRIVATE CITIZEN       htm  
EC7 08/22/2005 08/19/2005 Individual Consumer none       htm  
LET3 08/30/2005 08/30/2005 Drug Industry sanofi-aventis Group       pdf  
Signature: Steve Caffe, MD
EC8 09/12/2005 09/10/2005 Individual Consumer None       htm  
NEC1   09/16/2005 FDA FDA 09/19/2005 54925-54926 03/31/2006 pdf  
Signature: Jeffrey Shuren
EC9 11/17/2005 11/10/2005 Health Professional Mrs. Kim Salzwedel       htm  
LET4 01/13/2006 01/13/2006 Drug Industry Wyeth Pharmaceuticals (Wyeth) Confidential
Signature: Patricia Foti Mann
LET5 01/19/2006 01/18/2006 Drug Industry GlaxoSmithKline (GSK) Confidential
Signature: Sherry L. Watson
LET6 01/25/2006 01/24/2006 Drug Industry Wyeth Pharmaceuticals
Signature: Donald Esherick
LET7 02/22/2006 02/21/2006 Drug Industry AstraZeneca Pharmaceuticals, LP Confidential
Signature: Robert J. Timko, RPh., Ph.D.
LET8 02/21/2006 02/17/2006 Drug Industry GlaxoSmithKline (GSK) Confidential
Signature: Leo J. Lucisano, R.Ph.
LET9 03/20/2006 03/17/2006 Drug Industry Pfizer, Inc. Confidential
Signature: Leilani V. Kapili
EC10 03/21/2006 02/09/2006 Individual Consumer Mr. monty sims
EC11 04/21/2006 02/10/2006 Drug Industry Miss. laurie anspach
EC12 04/21/2006 03/19/2006 Drug Industry i have severe ankylosing spondylitis
LET10 05/01/2006 04/25/2006 Drug Industry Eli Lilly and Company (Lilly)
Signature: Joerg Pfeifer, PhD
LET11 05/25/2006 05/24/2006 Drug Industry Tibotec, Inc. Confidential
Signature: Thomas L. Pituk, PhD, RPh. RAC
LET12 06/12/2006 06/09/2006 Drug Industry Bristol-Myers Squibb Company (BMS) confidential
Signature: Rosa L. Zazzarini
EC13 07/10/2006 07/06/2006 Individual Consumer Mr. Dave Lowe
EC14 07/10/2006 07/06/2006 Individual Consumer Mr. Dave Lowe
TS1 09/01/2006 08/31/2006 Drug Industry Tibotec, Inc. CONFIDENTIAL
Signature: Thomas L. Pituk, PhD, RPh, RAC

Top | Up

Page last updated September 29, 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