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03D-0061: Guidance for Industry:  Comparability Protocols -- Chemistry,  Manufacturing, and Controls Information
Item Code
No.
Received Date
Submitter
Signature
FR Date
FR Page
Electronic form
EMC 5 10/24/2003 Dr. P. King Dr. P. King      
C 14 08/13/2003 Active Pharmaceutical Ingredients Committee CEFIC/APIC
Pieter van der Hoeven     pdf
C 13 07/25/2003 Pharmaceutical Research and Manufacturers of America (PhRMA)
Alice E. Till, PhD     txt, Attachment
C 12 07/14/2003 Bristol-Myers Squibb Pharmaceutical Research Institute
Laurie F Smaldone, MD     pdf
EC 3 06/24/2003 Farag, S Farag, S     html
EC 2 06/17/2003 Richardson, K Richardson, K     html
EMC 4 06/25/2003 Merck & Co., Inc. David W. Blois, PhD     txt, Attachment
C 11 07/02/2003 GlaxoSmithKline (GSK) Mary Faye S. Whisler, PhD     pdf
C 10 06/30/2003 Number Not Used        
C 9 06/26/2003 Johnson & Johnson Pharmaceutical research & Development, LLC
Sue Halley     pdf
C 8 06/25/2003 Novartis Pharmaceuticals, Corporation Joan A. Materna     pdf, Attachment
C 7 06/25/2003 Baxter Healthcare Corporation Marcia Marconi     pdf
C 6 06/25/2003 International Assn for Pharceutical Science and Technology (PDA)
William Stoedter, RAC     pdf, Attachment 1,
Attachment 2
C 5 06/25/2003 Aventis Pharmaceuticals, Inc. Steve Caffe, MD     pdf
C 4 06/25/2003 Centocor Thomas M. Hogan     pdf
C 3 06/17/2003 AstraZeneca Pharmaceuticals, LP Norbert R. Ealer     pdf
C 2 06/03/2003 MedImmune, Inc. Julia Goldstein     pdf
C 1 05/09/2003 Paul G. King Consulting/FAME SYSTEMS Paul G. King, PhD     pdf
EMC 3 04/25/2003 Dr. P. G. King Dr. P. G. King      
EMC 2 04/24/2003 Triangle PEERS Lowrie M. Beacham     txt, Attachment
EMC 1 04/24/2003 GlaxoSmithKline Amanda Willcox     txt, Attachment
EC 1 02/22/03 Fine Chemicals Corporation Dr. Barratt Easter       htm
NAD 1            02/25/03 8772 pdf, htm
GDL 1 02/20/03 Draft Guidance          pdf, Word

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Page last updated March 29, 2004

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