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| Dockets Entered
On March 25, 2005
Table of Contents
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| Docket #
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| Title
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1993P-0296
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| Amend regs re: placement of soft drink identity statements
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| 2000D-1392
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| Guidance for Industry on Botanical Drug Products
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2004D-0524
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| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004P-0351
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| Change the labeling and take further action to address the association of Viagra (Sildenafil) use and increased STD transmission, including HIV infection
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| 2005D-0004
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| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
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| 2005D-0022
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| International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| EC 32
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| Mr. Layne Hill
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| Vol #:
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| 140
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| EC 33
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| USAF Retired
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| Vol #:
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| 140
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| 1993P-0296
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| Amend regs re: placement of soft drink identity statements
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| MT
1
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| Telephone Conversation between FDA and American Beverage Association
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| Vol #:
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| 1
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| 2000D-1392
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| Guidance for Industry on Botanical Drug Products
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| EC
8
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| Mazal Plant Pharmaceuticals
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| Vol #:
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| 2
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 1123
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| Center for Veterinary Medicine
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| Vol #:
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| 445
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| EXB 1124
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| Center for Veterinary Medicine
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| Vol #:
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| 445
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC
15
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| Enzyme Technical Association
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| Vol #:
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| 4
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| 2004D-0524
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| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information
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| EC
3
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| Greenblum and Bernstein PLC
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| Vol #:
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| 1
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| EC
4
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| Apotex Inc.
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| Vol #:
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| 1
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| EC
5
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| Generic Pharmaceutical Association
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| Vol #:
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| 1
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| EC
12
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| United States Pharmacopeia (USP)
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| Vol #:
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| 5
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| EC
13
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| PhRMA
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| Vol #:
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| 5
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| EC
14
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| Hoffmann-La Roche, Inc.
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| Vol #:
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| 5
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| EC
15
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| Generic Pharmaceutical Association
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| Vol #:
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| 5
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| EC
16
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| GENENTECH
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| Vol #:
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| 5
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| 2004P-0351
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| Change the labeling and take further action to address the association of Viagra (Sildenafil) use and increased STD transmission, including HIV infection
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| C
8
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| Pfizer Inc
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| Vol #:
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| 1
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| 2005D-0004
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| Guidance for Industry on Nonclinical Safety Evaluation of Drug Combinations
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| EC
1
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| Alcon Research, LTD.
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| Vol #:
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| 1
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| 2005D-0022
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| International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
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| EC
1
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| GlaxoSmithKline
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| Vol #:
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| 1
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| EC
8
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| RapidTrials
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| Vol #:
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| 2
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| EC
9
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| South Georgia Medical Center
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| Vol #:
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| 2
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| EC
10
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| University of New Mexico Human Research Review Com
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| Vol #:
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| 2
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| EC
11
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| Overlake Hospital
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| Vol #:
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| 2
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| EC
12
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| UConn Health Center
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| Vol #:
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| 2
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| 2005N-0065
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| Risk Assessment of the Public Health Impact from Foodborne Listeria monocytogenes in Smoked Finfish
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| EC
1
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| Cherney Microbiological Services
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| Vol #:
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| 1
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| 2005P-0116
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| To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
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| ACK
1
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| HFA-305 toConsumer Health Alliance for Safe Medication
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| Vol #:
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| 1
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| CP
1
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| Consumer Health Alliance for Safe Medication
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| Vol #:
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| 1
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