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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
 
C14 03/17/2005 03/16/2005 Drug Industry Genentech, Inc.       pdf  
Signature: Robert L. Garnick, PhD
C15 03/18/2005 03/16/2005 Drug Association Generic Pharmaceutical Assn (GPhA)       pdf  
Signature: Kathleen D. Jaeger
EMC8 03/16/2005 03/16/2005 Drug Industry Biotechnology Industry Organization (BIO)       pdf  
Signature: Sara Radcliffe
EC12 03/16/2005 03/15/2005 Other Organization United States Pharmacopeia (USP)       pdf  
Signature: de Mars, Susan
EC13 03/17/2005 03/16/2005 Drug Association PhRMA       pdf  
Signature: Loew, Caroline
EC14 03/17/2005 03/16/2005 Drug Industry Hoffmann-La Roche, Inc.       pdf  
Signature: Talian, John
EC15 03/17/2005 03/16/2005 Drug Association Generic Pharmaceutical Association       pdf  
Signature: Jaeger, Kathleen
EC16 03/17/2005 03/17/2005 Drug Industry GENENTECH       pdf  
Signature: Garnick, Robert
CR1 07/15/2005 07/15/2005 Drug Industry Pharmaceutical Research and Manufacturers of America (PhRMA)
      pdf This is the corrected version of attachment A, page 13 found in C4 found in this docket.
Signature: Caroline Loew, PhD  
NM2   08/02/2005 FDA FDA 08/03/2005 44660-44662 11/01/2005 txt | pdf  
Signature: Jeffrey Shuren
C16 09/28/2005 09/27/2005 Private Industry Hyman, Phelps & McNamara PC       pdf  
Signature: Roger C Thies
C17 10/28/2005 10/28/2005 Device Association Advanced Medical Technology Association (AdvaMed)
      pdf  
Signature: Bernie Liebler
C18 11/01/2005 10/31/2005 Drug Industry Wyeth Pharmaceuticals (Wyeth)       pdf  
Signature: Roy J. Baranello, Jr.
C19 11/08/2005 11/07/2005 Drug Industry GlaxoSmithKline (GSK)       pdf  
Signature: Anne N. Stokley, M.S.P.H.
EMC9 04/14/2006 04/14/2006 Drug Industry Eli Lilly and Company (Lilly)       pdf  
Signature: Sidney Tauret
LET1 05/31/2006 05/31/2006 Federal Government
FDA/CDER       pdf  
  Signature: Steven K. Galson, M.D., M.P.H.
TR2 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/14/05 (PLENARY SESSION)
      pdf  
Signature: Scientific Workshop on 02/14/05 (PLE
TR3 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/14/05 (Breakout Session A) Physical Chemical Characterization & Impurities
      pdf  
Signature: Scientific Workshop on 02/14/05 (Brea
TR4 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/14/05 (Breakout Session A) Physical Chemical Characterization & Impurities
      pdf  
Signature: Scientific Workshop on 02/14/05 (Brea
TR5 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/14/05 (Breakout Session B) Biological Characterization & Impurities
      pdf  
Signature: Scientific Workshop on 02/14/05 (Brea
TR6 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/14/05 (Breakout Session B) Biological Characterization & Impurities
      pdf  
Signature: Scientific Workshop on 02/14/05 (Brea
TR7 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/14/05 (Breakout Session C) Pharmacology-Toxicology Studies
      pdf  
  Signature: Scientific Workshop on 02/14/05 (Brea
TR8 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/14/05 (Breakout Session C) Pharmacology-Toxicology Studies
      pdf  
Signature: Scientific Workshop on 02/14/05 (Brea
TR9 05/30/2006 05/30/2006 Federal Government
Scientific Workshop 02/14/05-Breakout Session D-Clinical Pharmacology Studies
      pdf  
Signature: Scientific Workshop 02/14/05-Breako
TR10 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/14/05-Breakout Session D-Clinical Pharmacology Studies
      pdf  
Signature: Scientific Workshop on 02/14/05-Brea
TR11 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/15/05 (PLENARY SESSION)
      pdf  
Signature: Scientific Workshop on 02/15/05 (PLE
TR12 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/15/05 (BREAKOUT SESSION E) Immunogenicity Studies
      pdf  
  Signature: Scientific Workshop on 02/15/05 (BRE
TR13 05/30/2006 05/30/2006 Federal Government Scientific Workshop on 02/15/05 (BREAKOUT SESSION E) Immunogenicity Studies
      pdf  
  Signature: Scientific Workshop on 02/15/05 (BRE
TR14 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/15/05 (BREAKOUT SESSION F) Clinical Safety and Efficacy Studies
      pdf  
Signature: Scientific Workshop on 02/15/05 (BRE
TR15 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/15/05 (BREAKOUT SESSION F) Clinical Safety and Efficacy Studies
      pdf  
Signature: Scientific Workshop on 02/15/05 (BRE
TR16 05/30/2006 05/30/2006 Federal Government
Scientific Workshop on 02/16/05 (PLENARY SESSION)
      pdf  
  Signature: Scientific Workshop on 02/16/05 (PLE

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