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| Dockets Entered
On February 24, 2005
Table of Contents
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| Docket #
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| Title
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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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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| 2003P-0437
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| refrain from covering the General and Plastic Surgery Devices panel of the Medical Devices Advsory committee on 10/14/03
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| 2004D-0377
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| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| 2005P-0085
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| Provide a generic form of Endrate Disodium Injection, USP in secondary package configurations of a single box containing one vial and or trays containing twenty-five vials per tray
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| C 2056
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| B. Greenberg
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| Vol #:
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| 300
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| C 2057
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| L. Kraft
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| Vol #:
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| 300
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| C 2058
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| L. Granger
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| Vol #:
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| 300
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| C 2059
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| P. Forcier
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| Vol #:
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| 300
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| C 2060
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| J. Davidson, MD
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| Vol #:
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| 300
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| C 2061
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| G. Barkett, DO, FACOG
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| Vol #:
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| 300
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| C 2062
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| J. Porter, MD
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| Vol #:
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| 300
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| C
2063
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| AAPLOG
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| Vol #:
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| 300
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| C
2064
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| AAPLOG
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| Vol #:
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| 300
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| C 2065
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| A. Dardano, MD
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| Vol #:
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| 300
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| C 2066
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| T. Boenig, MD (OBG)
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| Vol #:
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| 300
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| C 2067
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| E. Day, MD, FACOG
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| Vol #:
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| 300
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| C 2068
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| V. Lambert
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| Vol #:
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| 300
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| C 2069
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| C. Simms
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| Vol #:
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| 300
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| C 2070
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| J. Sullivan
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| Vol #:
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| 300
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| C 2071
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| J. Wallace
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| Vol #:
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| 300
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| C 2072
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| E. McGarvah, MD
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| Vol #:
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| 300
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| C
2073
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| Alaska State Legislature District 3
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| Vol #:
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| 300
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| C
2074
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| EverGreen Women's Health Care
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| Vol #:
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| 300
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| C 2075
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| J. Macer, MD
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| Vol #:
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| 300
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| C
2076
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| University of Chicago
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| Vol #:
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| 300
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| C
2077
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| Harvard Medical School
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| Vol #:
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| 300
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| C
2078
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| Forensic Nurse Specialists, Inc.
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| Vol #:
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| 300
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| C 2079
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| A. Nelson, MD
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| Vol #:
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| 300
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| C 2080
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| B. Skog RN, MA FN-SAC
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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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| RPT
1
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| Details Summary Report on Activities as a Consultant to Assist the CVM/FDA Animal Feed Safety S
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| Vol #:
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| 4
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| 2003P-0029
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| Remove metered-dose inhalers (MDI) containing moiety albuter
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| C
40
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| Florida Medicaid
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| Vol #:
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| 6
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| 2003P-0437
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| refrain from covering the General and Plastic Surgery Devices panel of the Medical Devices Advsory committee on 10/14/03
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| LET
1
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| HF-22 to Public Citizen Litigation Group
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| Vol #:
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| 1
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| 2004D-0377
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| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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| C
14
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| Schering Corporation (Schering-Plough)
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| Vol #:
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| 1
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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| C
146
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| Kleinfeld, Kaplan and Becker, LLP
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| Vol #:
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| 13
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| 2004N-0454
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| Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
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| C 32
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| K. Matthews
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| Vol #:
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| 30
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| C 33
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| L. Jones
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| Vol #:
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| 30
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| C 34
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| J. Maselli
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| Vol #:
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| 30
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| C 35
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| Illegible
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| Vol #:
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| 30
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| C 36
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| M. Sankari
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| Vol #:
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| 30
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| C 37
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| Mr and Mrs E. Phipps
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| Vol #:
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| 30
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| C 38
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| A. Stenhouse
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| Vol #:
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| 30
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| C 39
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| C. White
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| Vol #:
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| 30
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| C 40
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| D. Smith
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| Vol #:
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| 30
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| C 41
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| K. Klosno
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| Vol #:
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| 30
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| C 42
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| Integrated Healing Arts Professional Assn
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| Vol #:
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| 30
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| C 43
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| R. Donelson
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| Vol #:
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| 30
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| C 44
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| J. Green
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| Vol #:
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| 30
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| C 45
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| P. Suffredini
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| Vol #:
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| 30
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| C 46
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| M. Stricker
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| Vol #:
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| 30
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| C 47
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| G. Bryce, PhD
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| Vol #:
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| 30
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| C 48
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| K. Hoffmann
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| Vol #:
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| 30
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| C 49
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| P. Anderson
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| Vol #:
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| 30
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| C 50
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| P. Wilson
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| Vol #:
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| 30
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| C 51
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| S. Fincher
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| Vol #:
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| 30
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| C 52
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| P. Weeks
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| Vol #:
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| 30
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| 2005N-0038
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| Reporting of Adverse Events to Institutional Review Boards; Public Hearing
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| EAPE 108
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| Hardwick, Maureen
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| Vol #:
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| 1
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| EAPE 109
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| Cicero, Anita
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| Vol #:
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| 1
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| EAPE 110
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| Penn, Ruth
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| Vol #:
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| 1
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| EAPE 111
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| Williams, Robert
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| Vol #:
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| 1
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| EAPE 112
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| Clark, Deborah
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| Vol #:
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| 1
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| EAPE 113
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| Guzzo, Susan
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| Vol #:
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| 1
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| EAPE 114
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| Stewart, Janine
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| Vol #:
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| 1
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| EAPE 115
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| Murphy, Dianne
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| Vol #:
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| 1
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| EAPE 116
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| Iyasu, Solomon
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| Vol #:
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| 1
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| EAPE 117
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| McGillviray, Babara
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| Vol #:
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| 1
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| EAPE 118
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| Morris, Jennifer
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| Vol #:
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| 1
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| EAPE 119
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| cardinali, massimo
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| Vol #:
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| 1
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| EAPE 120
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| McCalister-Afflick, Brenda
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| Vol #:
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| 1
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| EAPE 121
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| Poon, Peter
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| Vol #:
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| 1
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|
| 2005P-0085
|
| Provide a generic form of Endrate Disodium Injection, USP in secondary package configurations of a single box containing one vial and or trays containing twenty-five vials per tray
|
| |
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| ACK
1
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| HFA-305 to McGuff Pharmaceuticals Inc.
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| Vol #:
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| 1
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| CP
1
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| McGuff Pharmaceuticals Inc.
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| Vol #:
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| 1
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