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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)      

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