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| Dockets Entered
On December 11, 2006
Table of Contents
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1980N-0042
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| Anticaries Drug Products for OTC Human Use
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| 1998P-0043
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| Permit the label statement of "Supplement Facts"
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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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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006N-0464
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| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0506
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| Request that the FDA announce an Advance Notice of Proposed Rulemaking regarding the use of symbols on the principal display panel that would communicate to consumers the healthfulness of foods.
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| 2006P-0507
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| to permit an ANDA Suitability for Methotrexate Injection
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC
135
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| American Academy of Dermatology
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| Vol #:
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| 14
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| EC
136
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| Loyola University Medical Center
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| Vol #:
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| 14
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| EC
137
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| Dr. Melissa Rubenstein
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| Vol #:
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| 14
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| 1980N-0042
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| Anticaries Drug Products for OTC Human Use
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| PDN
8
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| FDA/ORA
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| Vol #:
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| 34
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| 1998P-0043
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| Permit the label statement of "Supplement Facts"
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| SS
2
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| Supporting Statement
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| Vol #:
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| 1
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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
32
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| Mr. kent johnson
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| Vol #:
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| 8
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| EXB 88
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| R-83 Canada: Notice of Compliance from Health Canada
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| Vol #:
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| 94
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| EXB 89
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| R-84 European Union: Notified Body Certificates
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| Vol #:
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| 95
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| EXB 90
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| R-85 European Union: Medical Device Reporting Guidance Document
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| Vol #:
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| 96
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| EXB 91
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| R-86 European Union: Notified Body Audit Reports
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| Vol #:
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| 97
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| EXB 92
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| R-87 Quality Certificates
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| Vol #:
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| 98
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| EXB 93
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| R-88 Essential Requirements Checklist
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| Vol #:
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| 99
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| EXB 94
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| R-89 Not Used
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| Vol #:
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| 100
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| EXB 95
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| R-90 TMJ's Quality Manual (TMJ-001)
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| Vol #:
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| 101
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| EXB 96
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| R-91 Post Market Surveillance Program (SOP 217-001)
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| Vol #:
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| 102
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| EXB 97
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| R-92 Management Involvement (SOP 215-001)
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| Vol #:
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| 103
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| EXB 98
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| R-93 Year 2006 Management Meeing
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| Vol #:
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| 104
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| EXB 99
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| R-94 Year 2005 Management Meeing
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| Vol #:
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| 105
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| EXB 100
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| R-95 Year 2004 Management Meeting
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| Vol #:
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| 106
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| EXB 101
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| R-96 Rist Analysis
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| Vol #:
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| 107
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| EXB 102
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| R-97 FDA Correspondence 1/7/92 Form 483
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| Vol #:
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| 108
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| EXB 103
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| R-98 FDA Correspondence 1/27/92 Warning Letter
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| Vol #:
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| 109
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| EXB 104
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| R-99 Not Used
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| Vol #:
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| 110
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| EXB 105
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| R-100 TMJ's Response to 1/7/92 FDA Form 483
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| Vol #:
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| 111
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| EXB 106
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| R-101 Letter of 12/2/92, Marketing & Distribution and Preamendment
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| Vol #:
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| 112
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| EXB 107
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| R-102 FDA Correspondence, Form 483
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| Vol #:
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| 113
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| EXB 108
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| R-103 FDA Correspondence, Letter of 10/25/93
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| Vol #:
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| 114
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| EXB 109
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| R-104 FDA Correspondence, Form 483
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| Vol #:
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| 115
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| EXB 110
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| R-105 TMJI Response to 483s
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| Vol #:
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| 116
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| EXB 111
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| R-106 FDA Letter of 7/15/96
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| Vol #:
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| 117
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| EXB 112
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| R-107 7/31/96: FDA Website Information on Medical Device Reporting
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| Vol #:
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| 118
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| EXB 113
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| R-108 5/14/97 : FDA 483
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| Vol #:
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| 119
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| EXB 114
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| R-109 6/12/97: EIR Report
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| Vol #:
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| 120
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| EXB 115
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| R-110 2/25/99 EIR Report for 11/98 Inspection
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| Vol #:
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| 121
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| EXB 116
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| R-111 6/7/99: FDA -483
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| Vol #:
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| 122
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| EXB 117
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| R-112 6/5/2000: FDA -483
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| Vol #:
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| 123
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| EXB 118
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| R-113 10/10/2000: FDA -483
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| Vol #:
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| 124
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| EXB 119
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| R-114 1/4/2001: FDA 483
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| Vol #:
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| 125
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| EXB 120
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| R-115 1/5/2001: P000023 Approval Letter for the TMJ Fossa Eminence/Condoylar Prosthesis Syste
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| Vol #:
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| 126
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| EXB 121
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| R-116 2/27/2001: P000035 Approval Letter for the TMJ Fossa Eminence Prosthesis
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| Vol #:
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| 127
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| EXB 122
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| R-117 2/22/2002: FDA-483
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| Vol #:
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| 128
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| EXB 123
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| R-118 3/27/2002: FDA Warning Letter
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| Vol #:
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| 129
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| EXB 124
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| R-119 4/18/2002: TMJI Response to FDA 483
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| Vol #:
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| 130
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| EXB 125
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| R-120 5/2//2002: TMJI Notes regarding FDA Meeting
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| Vol #:
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| 131
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| EXB 126
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| R-121 5/2/2002 TMJI's Response to FDA-483
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| Vol #:
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| 132
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| EXB 127
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| R-122 10/1/2002 TMJI's Letter to Regina Barrell
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| Vol #:
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| 133
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| EXB 128
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| R-123 10/23/2002 FDA Untitled Letter
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| Vol #:
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| 134
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| EXB 129
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| R-124 11/1/2002 TMJI Response to FDA FDR Letter
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| Vol #:
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| 135
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| EXB 130
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| R-125 11/21/2002 FDA Telephone call notes
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| Vol #:
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| 136
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| EXB 131
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| R-126 11/25/2002 Submission of Complaint Handking Procedures
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| Vol #:
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| 137
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| EC
2818
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| Mrs. Melissa Ashley
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| Vol #:
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| 16
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| EC
2967
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| Mrs. Jo Ann Gerling, IBCLC
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| Vol #:
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| 16
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| EC
2968
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| Mrs. Pam Hillary
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| Vol #:
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| 16
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| EC
2969
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| Mrs. PAtricia HAck
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| Vol #:
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| 16
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| EC
2970
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| Mr. Larry Burnside
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| Vol #:
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| 16
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| EC
2971
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| Mrs. Patricia Burnside
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| Vol #:
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| 16
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| EC
2972
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| Mrs. Veronica O'Hagan
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| Vol #:
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| 16
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| EC
2973
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| Mr. Jaspar von Buelow
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| Vol #:
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| 16
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| EC
2974
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| Mr. Carl von Buelow
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| Vol #:
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| 16
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| EC
2975
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| Mr. Roland von Buelow
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| Vol #:
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| 16
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| EC
2976
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| Mr. Arthur Meola
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| Vol #:
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| 16
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| EC
2977
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| Mrs. Barbara Jones
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| Vol #:
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| 16
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| EC
2978
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| Mr. Geoffrey Federmeier
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| Vol #:
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| 16
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| EC
2979
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| Mrs. Judith Darweesh
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| Vol #:
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| 16
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| EC
2980
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| Mrs. Roisin ONeill
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| Vol #:
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| 16
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| EC
2981
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| Mrs. Julie Skeen
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| Vol #:
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| 16
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| EC
2982
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| Mrs. Ellen Gross
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| Vol #:
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| 16
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| EC
2983
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| Mr. Rudy Guerrero
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| Vol #:
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| 16
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| EC
2984
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| Pharmaceutical Representative
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| Vol #:
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| 16
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| EC
2985
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| Mrs. Linda Penn
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| Vol #:
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| 16
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| 2006N-0464
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| Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing
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| EC 9
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| EC 10
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| CDISC
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| Vol #:
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| 1
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| EC 11
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| CRIX International, Association
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| Vol #:
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| 1
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| EC 12
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| Mr. Robert Rainer
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| Vol #:
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| 1
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| EC 13
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| Octagon Research Solutions
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| Vol #:
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| 1
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| EC 14
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| Genzyme Corporation
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| Vol #:
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| 1
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| EC 15
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| SAS
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| Vol #:
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| 1
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| EC 16
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| CommonPractice.org
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| Vol #:
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| 1
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| EC 17
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| ThinSpring
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| Vol #:
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| 1
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| EC 18
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| Genentech, Inc.
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| Vol #:
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| 1
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| EC 19
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| MedWrite, Inc.
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| Vol #:
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| 1
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| EC 20
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| Northrop Grumman Corporation
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| Vol #:
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| 1
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| EC
438
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| Ms. Susan Grisham
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| Vol #:
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| 7
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| EC
439
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| Ms. Janet Diehl
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| Vol #:
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| 7
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