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| Dockets Entered
On March 17, 2005
Table of Contents
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| Docket #
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| Title
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| 1989V-0161
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| VARIANCE FOR GRAND COULEE DAM LASER SHOW
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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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| Draft Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information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-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004P-0349
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| Action on Products containing added Mercury
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| 2004P-0357
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| Determine that an advisory opinion or exemption is not needed in accorance with FDA regulations for for Automatic External Defrillators
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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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| 2005N-0067
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| Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Drug Metabolizing Enzyme Genotyping System
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| 2005N-0071
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| Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Instrumentation for Clinical Multiplex Test Systems
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| 2005P-0107
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| Glycoprotein IIb/IIIa Inhibitors - Tirofiban, Lamifiban, Eptifibatide, and Abciximab for Acute Coronary Syndromes in Women
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| 1977N-0094
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| OTC Internal Analgesic, Antipyretic & Antirheumatic Products
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| SUP
54
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| Clinical Trial Service Unit & epidemiological Studies Unit (CTSU) University of Oxford
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| Vol #:
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| 257
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| C 12
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| J. Williford
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| Vol #:
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| 142
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| C 13
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| C. Ritch
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| Vol #:
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| 142
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| 1989V-0161
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| VARIANCE FOR GRAND COULEE DAM LASER SHOW
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| EXP 3
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| Bureau of Reclamation
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
15697
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| NBTY Inc.
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| Vol #:
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| 138
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 2083
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| B and B Wheeler
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| Vol #:
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| 300
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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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| C
11
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| National Grain and Feed 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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| C
2
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| AstraZeneca LP
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| Vol #:
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| 1
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| C
3
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| Sanofi-Synthelabo, Inc. and Aventis Pharmaceuticals
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| Vol #:
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| 1
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| | | | | | | | |
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| C 199
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| Form Letters
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| Vol #:
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| 28
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| C
13
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| Novo Nordisk Inc.
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| Vol #:
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| 4
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| C
14
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| Genentech, Inc.
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| Vol #:
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| 4
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| SUP
1
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| Pharmaceutical Research and Manufacturers of America (PhRMA)
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| Vol #:
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| 4
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| 2004P-0349
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| Action on Products containing added Mercury
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| C
7
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| Coalition for Mercury-free Drugs
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| Vol #:
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| 1
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| 2004P-0357
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| Determine that an advisory opinion or exemption is not needed in accorance with FDA regulations for for Automatic External Defrillators
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| LET
2
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| HFZ-001 to City of Arlington Texas
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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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| C
2
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| Methodist Healthcare IRB
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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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| C
1
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| University of Florida, Aquatic Food Products Program
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| Vol #:
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| 1
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| 2005N-0067
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| Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Drug Metabolizing Enzyme Genotyping System
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| BKG
1
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| Reference 1 found in 70FR11865
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| Vol #:
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| 1
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| 2005N-0071
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| Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Instrumentation for Clinical Multiplex Test Systems
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| BKG
1
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| Ref 1 found in 70FR11867
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| Vol #:
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| 1
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| 2005P-0107
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| Glycoprotein IIb/IIIa Inhibitors - Tirofiban, Lamifiban, Eptifibatide, and Abciximab for Acute Coronary Syndromes in Women
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| ACK
1
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| HFA-305 to Univertsity of California, San Francisco
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| Vol #:
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| 1
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| CP
1
Attachment
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| Univertsity of California, San Francisco
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| Vol #:
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| 1
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