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| Dockets Entered
On March 3, 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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| 1983G-0318
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| GUM ACACIA IN ALCOHOLIC BEVERAGES
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| 1992V-0225
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| Laser Light Show
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| 1993N-0348
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| Lead in Food & Color Additives & GRAS Ingredients
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| 1994P-0036
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| Req labeling of trans fatty acid & prohibit deceptive claims
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| 2002V-0382
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| Infrared Laser Aiming Devices
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| 2003F-0023
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| Creamers for Use in Alcoholic Beverages
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| 2003N-0528
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| Revision of the Requirements for Spore-Forming Microorganisms
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| 2004D-0478
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information
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| 2004D-0494
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| Guidance for Industry on Changes to an Approved NDA or ANDA; Specifications Use of Enforcement Discretion for Compendial Changes
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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-0269
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| Radioactive Drug Research Committees; Agency Information Collection Activities
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| 2004N-0355
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| Scientific Considerations Related to Developing Follow-on Protein Products
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| 2004N-0395
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
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| 2004P-0464
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| Vitamin D and Calcium and Reduced Risk of Osteoporosis
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| 2005D-0056
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| Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular a
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 1980N-0208
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| Biological Products; Bacterial Vaccines and Toxiods
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| C 8
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| C. Thayer
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| Vol #:
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| 142
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| C 9
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| B. Franz
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| Vol #:
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| 142
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| C 10
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| P. Veldhuis
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| Vol #:
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| 142
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| EC 30
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| Mr. Brian Cox
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| Vol #:
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| 140
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| 1983G-0318
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| GUM ACACIA IN ALCOHOLIC BEVERAGES
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1992V-0225
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| Laser Light Show
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| VRA
3
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| HFZ-300 to Forum Developers Limited Partnership
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| Vol #:
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| 1
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| 1993N-0348
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| Lead in Food & Color Additives & GRAS Ingredients
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| NWL
1
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| FDA
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| Vol #:
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| 3
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| | | | | | | | |
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| 1994P-0036
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| Req labeling of trans fatty acid & prohibit deceptive claims
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| C 2652
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| H. Hansen
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| Vol #:
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| 90
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| 2002N-0277
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| Bioterrorism; Establishment & Maintenance of Records
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| NAL
1
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| FDA
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| Vol #:
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| 16
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| NCR
2
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| FDA
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| Vol #:
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| 16
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| SS
1
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| Supporting Statement
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| Vol #:
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| 16
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| 2002V-0382
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| Infrared Laser Aiming Devices
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| AMD
1
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| Laser Devices, Inc.
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| Vol #:
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| 1
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 2003F-0023
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| Creamers for Use in Alcoholic Beverages
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| BKG
1
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| Background Material Refs 1 - 9 70FR8032
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| Vol #:
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| 2
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| NFR
1
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| FDA
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| Vol #:
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| 1
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| 2003N-0528
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| Revision of the Requirements for Spore-Forming Microorganisms
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| NAD
1
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| FDA
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| Vol #:
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| 1
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| 2004D-0369
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| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use
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| EMC 1071
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| P Zarchin
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| Vol #:
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| 14
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| EMC 1072
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| T Dolan
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| Vol #:
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| 14
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| EMC 1073
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| B Cutler
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| Vol #:
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| 14
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| EMC 1074
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| J Siegel
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| Vol #:
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| 14
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| EMC
1075
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| Friends of the Earth
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| Vol #:
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| 14
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| EMC 1076
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| B Stockton
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| Vol #:
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| 14
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| EMC 1077
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| B Smawley
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| Vol #:
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| 14
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| EMC 1078
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| M Hill
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| Vol #:
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| 14
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| EMC 1079
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| F Stiff
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| Vol #:
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| 14
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| EMC 1080
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| S Abbott
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| Vol #:
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| 14
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| EMC 1081
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| L McAllister
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| Vol #:
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| 14
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| EMC 1082
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| J Gonzales
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| Vol #:
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| 14
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| EMC 1083
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| M Bird
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| Vol #:
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| 14
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| EMC 1084
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| B Winholtz
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| Vol #:
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| 14
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| EMC 1085
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| L Hutchins
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| Vol #:
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| 14
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| EMC 1086
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| M White
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| Vol #:
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| 14
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| EMC 1198
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| E Heisler
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| Vol #:
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| 18
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| EMC 1199
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| J Mueller
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| Vol #:
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| 18
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| 2004D-0478
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| Guidance for Industry and Food and Drug Administration; Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information
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| EC
2
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| SEGURITECH PRIVADA S.A. DE C.V.
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| Vol #:
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| 1
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| 2004D-0494
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| Guidance for Industry on Changes to an Approved NDA or ANDA; Specifications Use of Enforcement Discretion for Compendial Changes
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| EC
1
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| Eli Lilly and Company
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| Vol #:
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| 1
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|
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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
1 , attachment |
| Eon Labs, Inc.
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| Vol #:
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| 1
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| |
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| 2004N-0269
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| Radioactive Drug Research Committees; Agency Information Collection Activities
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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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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| NEC
1
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| FDA
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| Vol #:
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| 4
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| 2004N-0395
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
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| NAL
1
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| FDA
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| Vol #:
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| 1
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| SS
1
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| Supporting Statement
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| Vol #:
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| 1
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| 2004P-0464
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| Vitamin D and Calcium and Reduced Risk of Osteoporosis
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| LET
2
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| Beverage Institute for Health and Wellness (BHWI)
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| Vol #:
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| 9
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| RC
1
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| American Longevity Inc
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| Vol #:
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| 16
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| |
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| 2005D-0056
|
| Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular a
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|
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| BKG
1
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| Background Material Refs 1 - 5 70FR9083
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| Vol #:
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| 1
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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|
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| NAD
1
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| FDA
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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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| APE 6
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| CIOMS VI Working Group
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| Vol #:
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| 1
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| EAPE 154
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| Foss, Jim
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| Vol #:
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| 1
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| EAPE 155
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| Waterman, Paula Squire
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| Vol #:
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| 1
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| EAPE 156
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| Lasswell, M'Linda
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| Vol #:
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| 1
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