p df
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 | Most Recent

2004N-0355: Scientific Considerations Related to Developing Follow-up Protein Products
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
NM1   08/11/2004 FDA FDA 08/16/2004 50386-50388 11/12/2004 pdf Public Workshop will be held 9/14-15/04
Signature: SHUREN, JEFFREY
NCR1   09/01/2004 FDA FDA 09/07/2004 54149-54149   pdf  
Signature: William K. Hubbard
C1 09/14/2004 09/14/2004 Private Industry Biogen Idec       pdf  
Signature: Kathleen Kelley
EC1 09/23/2004 09/22/2004 Health Professional Ms. J LeClair       html  
Signature: LeClair, J
EC2 09/23/2004 09/22/2004 Health Professional Ms. J LeClair       html  
Signature: LeClair, J
EC3 09/23/2004 09/22/2004 Health Professional Ms. J LeClair       html  
Signature: LeClair, J
EC4 09/23/2004 09/22/2004 Health Professional Ms. J Leclair       html  
Signature: Leclair, J
EC5 09/23/2004 09/22/2004 Health Professional Ms. J Leclair       html  
Signature: Leclair, J
EC6 09/23/2004 09/22/2004 Health Professional Ms. J LeClair       html  
Signature: LeClair, J
EC7 09/23/2004 09/22/2004 Health Professional Mrs. J LeClair       html  
Signature: LeClair, J
EC8 09/23/2004 09/22/2004 Health Professional Ms. J LeClair       html  
Signature: LeClair, J
EMC1 09/22/2004 09/22/2004 Device Industry Biotechnology Industry Organization (BIO)       text, Attachment  
Signature: Jessica S. Oldham
EMC2 09/22/2004 09/22/2004 Individual Consumer J. Leclair        
TS1 09/27/2004 09/22/2004 Drug Industry Novartis Pharmaceuticals Corporation (Novartis)       pdf  
Signature: David Drake
EC9 10/19/2004 10/18/2004 Drug Industry Pharmaceutical Scientist Inc       html  
Signature: Niazi, Sarfaraz K.
TR1 10/26/2004 10/26/2004 Federal Government
 Transcripts       tr01, tr02, tr03, tr04, tr05, tr06 Workshop Scientific considerations related to developing following-on protein products Dockets No. 2004N- 0355 9/14-15/04
Signature: Transcripts
EXT1 11/08/2004 11/08/2004 Association Biotechnology Industry Organization (BIO)       htm  
Signature: Sara Radcliffe, MPH
C2 11/12/2004 11/11/2004 Drug Industry Genentech, Inc.       pdf  
Signature: Robert L. Garnick, PhD
EC10 11/12/2004 11/11/2004 Drug Industry Rakoczy Molino Mazzochi Siwik LLP       htm  
Signature: Siwik, Christine
C3 11/12/2004 11/12/2004 Drug Industry Amgen, Inc. (Amgen)       pdf  
Signature: Kenneth Seamon, PhD
C4 11/12/2004 11/12/2004 Drug Industry Pharmaceutical Research and Manufacturers of America (PhRMA)   pdf  
Signature: Caroline J. Loew, PhD
C5 11/12/2004 11/12/2004 Drig Industry Sicor, Inc.       pdf  
Signature: Suzanne M. Sensabaugh,MS,MBA
C6 11/14/2004 11/12/2004 Drug Industry Pfizer, Inc.       pdf  
Signature: Frederick W. Telling, PhD
EMC3 11/12/2004 11/12/2004 Assocaition Plasma Protein Therapeutics Assn (PPTA)      

pdf
txt

 
Signature: Mary Gustafson
EMC4 11/12/2004 11/12/2004 Drug Industry Pfizer, Inc.       pdf  
Signature: Frederick W. Telling, PhD
EC11 11/15/2004 11/12/2004 Drug Industry Novartis Pharmaceuticals Corporation       html  
Signature: Hukkelhoven, Mathias
C7 11/17/2004 11/12/2004 Association Plasma Protein Therapeutics Assn (PPTA)       pdf  
Signature: Mary Gustafson
C8 11/24/2004 11/23/2004 Drug Industry Schering Corporation (Schering Plough)       pdf  
Signature: Ronald Garutti, MD
C9 12/09/2004 12/09/2004 Drug Association Generic Pharmaceutical Assn (GPhA)       pdf  
Signature: Kathleen Jaeger, Esq
C10 12/15/2004 12/15/2004 Drug Industry Barr Laboratories et al.       htm  
Signature: Christine J. Siwik
EMC5 12/14/2004 12/14/2004 Drug Industry Biotechnology Industry Organization (BIO)       pdf  
Signature: Sara Radcliffe, MPH
EMC6 01/05/2005 01/05/2005 Association Plasma Protein Therapeutics Assn (PPTA)       pdf  
Signature: Mary Gustafson
C11 01/10/2005 01/06/2005 Association Plasma Protein Therapeutics Assn (PPTA)       pdf  
Signature: Mary Gustafson
C12 02/08/2005 02/07/2005 Drug Industry Hoffman-La Roche, Inc. (Roche)       pdf  
Signature: Michael Doherty
EMC7 02/07/2005 02/07/2005 Private Industry Hoffman-La Roche, Inc. (Roche)       pdf  
Signature: John Talian, PhD
NEC1   02/11/2005 FDA FDA 02/16/2005 7950-7951 03/16/2005 txt | pdf  
Signature: Jeffrey Shuren
SUP1 03/16/2005 03/16/2005 Association Pharmaceutical Research and Manufacturers of America (PhRMA) pdf  
Signature: Caroline J. Loew
C13 03/16/2005 03/15/2005 Drug Industry Novo Nordisk Inc.       pdf  
Signature: Jim Shehan and Mary Ann McElligott
C14 03/17/2005 03/16/2005 Drug Industry Genentech, Inc.       pdf  
Signature: Robert L. Garnick, PhD

Top | Up | Most Recent

Page last updated April 25, 2006 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