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| Dockets Entered
On September 5, 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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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2001D-0489
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| Establishment & Operation of Clinical Trial Monitoring Comm
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006P-0114
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| Refrain from taking administrative action regarding approval and/or effective date of final approval of any and all ANDAs for a generic version of Metrogel-Vaginal 0.75%
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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| 2006P-0158
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| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
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| 2006P-0186
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| Withdraw new drug application (NDA 21-179) for Renagel Tablets (sevelamer hydrochloride) 400 and 800 mg
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for filing an ANDA
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| 2006P-0310
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| Compel the Agency to follow requirements of the Drug Listing Act of 1972
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| 2006P-0346
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| Ban Marketing of Estratest, Estratest H.S. and Syntest D.S. and Syntest H.S. associated with Menopause
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| 2006P-0360
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| Determine that the discontinued formulation of Carbocaine Injection, 3% supplied in 1.8 mL cartridge was not discontinued for safety and efficacy reasons
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| 2006P-0364
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| Reformulation of central nervous system (CNS) stimulant drugs
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| 2006P-0365
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| Citizen Petition Urging FDA to Take Regulatory Action to Safeguard the Public from Violative Dental Devices Distributed by Five Companies, Including Devices Manufactured in Unregistered Facilities and
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EC 3
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| Mrs. Peggy Brown
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| Vol #:
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| 4
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| EC 4
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| Ms. Parisa Fitz-Henley
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| Vol #:
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| 4
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| EC 5
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| Miss. Laura Laine-McInnis
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| Vol #:
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| 4
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| EMC 5
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| D. McNabb
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| Vol #:
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| 10
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 649
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| M. Ruhl
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| Vol #:
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| 24
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| 2001D-0489
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| Establishment & Operation of Clinical Trial Monitoring Comm
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| EC 18
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| 2005D-0169
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| Guidance on Useful Written Consumer Medication Information (CMI)
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| EC 19
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| Mr. Dave Lowe
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| Vol #:
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| 2
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| | | | | | | | |
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| 2005D-0202
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| Guidance for Industry on Bar Code Label Requirements; Questions and Answers
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| |
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| EC 5
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| Mr. Dave Lowe
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| Vol #:
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| 1
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| MO 17
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| TMJ Implants, Inc., and Robert W. Christensen and Maureen K. Mooney
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| Vol #:
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| 6
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| EC 33269
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| Florida Pharmacy Association
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| Vol #:
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| 197
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| EC 33270
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| Ms. Kerry Finn
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| Vol #:
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| 197
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| EC 33271
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| Ms. Delma J. Soriano
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| Vol #:
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| 197
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| EMC 3850
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| L. Mercury
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| Vol #:
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| 195
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| EMC 3851
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| P. Fyne
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| Vol #:
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| 195
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| EMC 3852
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| T. Frank
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| Vol #:
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| 195
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| EMC 3853
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| C. Benoit
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| Vol #:
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| 195
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| EMC 3854
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| K. Dydo
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| Vol #:
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| 195
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| EMC 3855
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| N. Joyner
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| Vol #:
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| 195
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| EMC 3856
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| J. Jenschke
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| Vol #:
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| 195
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| EMC 3857
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| K. Reichert
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| Vol #:
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| 195
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| EMC 3858
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| V. Dorris
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| Vol #:
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| 195
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| EMC 3859
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| R. Myers
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| Vol #:
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| 195
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| EMC 3860
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| C. St. John-Harden
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| Vol #:
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| 195
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| EMC 3861
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| E. Barkley
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| Vol #:
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| 195
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| EC 1
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| Mr. Darryl Wellinghoff
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| Vol #:
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| 1
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| EC 1
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| Ms. Shonagh Home
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| Vol #:
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| 3
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| EC 2
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| Ms. Kimela Lanford
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| Vol #:
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| 3
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| EC 3
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| Mr. Gary Herring
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| Vol #:
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| 3
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| EC 4
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| Mrs. Karen Newman
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| Vol #:
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| 3
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| EC 5
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| Mr. Venkat Rangamani
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| Vol #:
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| 3
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| EC 6
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| Concerned Citizen : ending mercury in dental work
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| Vol #:
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| 3
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| EC 7
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| Ms. Lauri Pruett
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| Vol #:
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| 3
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| EC 8
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| Ms. Judy Klien
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| Vol #:
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| 3
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| EC 9
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| Mr. Roger Nelson
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| Vol #:
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| 3
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| EC 10
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| American Dental Association
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| Vol #:
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| 3
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| EC 11
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| American Dental Association
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| Vol #:
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| 3
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| EC 12
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| American Dental Association
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| Vol #:
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| 3
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| EC 13
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| Mrs. Sandra osborne
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| Vol #:
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| 3
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| EC 14
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| Dr. B Lafferty
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| Vol #:
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| 3
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| EC 15
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| Mr. Steven White DTR
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| Vol #:
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| 3
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| EC 16
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| Mrs. Lisa Porter
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| Vol #:
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| 3
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| EC 17
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| Mr. Lane Weaver
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| Vol #:
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| 3
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| EC 18
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| Ms. RoseMary Volpe
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| Vol #:
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| 3
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| EC 19
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| Dr. Pauline Hattemer
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| Vol #:
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| 3
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| EC 20
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| Mrs. Diane Harrell
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| Vol #:
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| 3
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| EC 21
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| Mr. Max Kane
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| Vol #:
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| 3
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| EC 22
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| IAOMT
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| Vol #:
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| 4
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| EC 23
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| Mr. Charles Spencer
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| Vol #:
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| 3
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| EC 24
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| Univ. of Georgia
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| Vol #:
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| 3
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| EC 25
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| Mrs. Teresa Irvin
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| Vol #:
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| 3
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| EC 26
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| Mrs. Christine Cave
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| Vol #:
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| 3
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| EC 27
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| Ms. Judith Ross
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| Vol #:
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| 3
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| EC 28
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| Mrs. Monica Thomas
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| Vol #:
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| 3
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| EC 29
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| Ms. Bobby McClintock
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| Vol #:
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| 3
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| EC 30
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| Mrs. Diana Green
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| Vol #:
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| 3
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| EC 31
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| Mountain View Citizens for Safe Drinking Water
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| Vol #:
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| 3
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| EC 32
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| Dr. William Harris
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| Vol #:
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| 3
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| EC 33
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| Fluoride Action Network
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| Vol #:
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| 3
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| EC 34
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| Mrs. VERNA DISTAD
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| Vol #:
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| 3
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| EC 35
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| Mrs. Maggie Overdahl
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| Vol #:
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| 3
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| EC 36
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| Citizen Political Activist
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| Vol #:
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| 3
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| EC 37
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| Mr. J. Michael Bryan
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| Vol #:
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| 3
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| EC 38
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| Ms. Arran Thomson
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| Vol #:
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| 3
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| EC 39
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| Mr. Pondurenga Das
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| Vol #:
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| 3
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| EC 40
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| Mrs. Michele Badanek
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| Vol #:
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| 3
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| |
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| EC 41
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| None
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| Vol #:
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| 3
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| |
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| EC 42
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| Dr. Steve Markus
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| Vol #:
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| 3
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| |
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| EC 43
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| Mr. Daniel McCamman
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| Vol #:
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| 3
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| |
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| EC 44
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| Mrs. Diane Sperber
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| Vol #:
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| 3
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| |
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| EC 45
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| The Photo Shoppe
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| Vol #:
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| 3
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| |
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| EC 46
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| Mr. Ulf Bengtsson
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| Vol #:
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| 3
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| |
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| EC 47
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| Dr. Rosemary Fecteau
|
| Vol #:
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| 3
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| |
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| EC 48
|
| Wellness Rx, Inc.
|
| Vol #:
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| 3
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| | | | | | | |
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| |
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| EC 49
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| Dr. Andrew Zakarian
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| Vol #:
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| 3
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| |
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| EC 50
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| Mrs. Marilyn Hageman
|
| Vol #:
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| 3
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| |
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| EC 51
|
| Mothers Against Mercury Amalgam / MAMA
|
| Vol #:
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| 3
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| |
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| EC 52
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| Ms. Carolyn Dohrenwend
|
| Vol #:
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| 3
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| |
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| EMC 38
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| Italian Association for Metals and Biocompatibility Research (A.I.R.M.E.B.)
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| Vol #:
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| 2
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| |
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| EMC 39
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| H. Downing
|
| Vol #:
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| 2
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| |
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| EMC 40
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| O. Woodward
|
| Vol #:
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| 2
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| |
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| EMC 41
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| T. Danysh
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| Vol #:
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| 2
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| EMC 42
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| J. Grossman
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| Vol #:
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| 2
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| EMC 43
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| R. Kerger
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| Vol #:
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| 2
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| EMC 44
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| V. WIlliams
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| Vol #:
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| 2
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| |
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| EMC 45
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| B. Levy, DDS
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| Vol #:
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| 2
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| |
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| EMC 46
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| J. Fritzler
|
| Vol #:
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| 2
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| |
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| EMC 47
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| J. Plumb
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| Vol #:
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| 2
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| |
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| EMC 48
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| S. Pearce
|
| Vol #:
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| 2
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| |
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| EMC 49
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| D. Joelkers
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| Vol #:
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| 2
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| |
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| EMC 50
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| S. Holmstrom
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| Vol #:
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| 2
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| |
|
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| EMC 51
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| C. Griggs
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| Vol #:
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| 2
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| |
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| EMC 52
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| T. Nocera, B.S., M.A.
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| Vol #:
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| 2
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| EMC 53
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| K. Morris
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| Vol #:
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| 2
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| |
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| EMC 54
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| L. Pellegrini
|
| Vol #:
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| 2
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| |
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| EMC 55
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| D. Mariano
|
| Vol #:
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| 2
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| |
|
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| EMC 56
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| L. Piatt, MSN, RN
|
| Vol #:
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| 2
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| |
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| EMC 57
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| Dr. K. Chai
|
| Vol #:
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| 2
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| |
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| EMC 58
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| J. Delgado
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| Vol #:
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| 2
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| |
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| EMC 59
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| D. Coomer
|
| Vol #:
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| 2
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| |
|
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| EMC 60
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| Dr. R. McGinn
|
| Vol #:
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| 2
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| |
|
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| EMC 61
|
| No signature
|
| Vol #:
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| 2
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| |
|
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| EMC 62
|
| C. Skipper
|
| Vol #:
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| 2
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| |
|
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| EMC 63
|
| Dr. B. Dawson, DC
|
| Vol #:
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| 2
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| |
|
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| EMC 64
|
| B. Huffman
|
| Vol #:
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| 2
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| |
|
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| EMC 65
|
| J. Delgado
|
| Vol #:
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| 2
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| |
|
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| EMC 66
|
| D. Boone
|
| Vol #:
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| 2
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| |
|
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| EMC 67
|
| B. Shelton, MD
|
| Vol #:
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| 2
|
| |
|
|
| EMC 68
|
| M. Bernstein, M.D., M.S., J.D.
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 69
|
| W. Glaros, DDS
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 70
|
| J. Marcus
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
| |
|
| EMC 71
|
| D. MArtin
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 72
|
| O. Duke
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 73
|
| S. Dilks
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 74
|
| L. Crosby
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 75
|
| Susan
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 76
|
| Dr. M. Thoennes
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 77
|
| M. Ortega
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 78
|
| J. Stuart
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 79
|
| V. Walton
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 80
|
| S. Scheckner, DMD
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 81
|
| Y. Tal
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 82
|
| K. Peterson
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 83
|
| J. Marich
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 84
|
| E. BRandt
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 85
|
| J. Marich
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 86
|
| D. MArtin
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 87
|
| C. Spencer
|
| Vol #:
|
| 2
|
| |
|
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| EMC 88
|
| T. White
|
| Vol #:
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| 2
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| |
|
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| EMC 89
|
| B. Shands
|
| Vol #:
|
| 2
|
| |
|
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| EMC 90
|
| C. Geyer, RDH
|
| Vol #:
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| 2
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| |
|
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| EMC 91
|
| J. Schaefer
|
| Vol #:
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| 2
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| |
|
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| EMC 92
|
| L. George
|
| Vol #:
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| 2
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| |
|
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| EMC 93
|
| B. Scott, RDH
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 94
|
| S. Kreider, MSIT, RN, CPC
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 95
|
| J. Parfitt
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0114
|
| Refrain from taking administrative action regarding approval and/or effective date of final approval of any and all ANDAs for a generic version of Metrogel-Vaginal 0.75%
|
| |
|
|
| EC 1
|
| Mr. Dave Lowe
|
| Vol #:
|
| 2
|
|
| |
|
| 2006P-0151
|
| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
|
| |
|
|
| EC 720
|
| Mrs. tracy sutton
|
| Vol #:
|
| 3
|
| |
|
|
| 2006P-0158
|
| Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
|
| |
|
|
| EC 1
|
| McNeil Nutritionals, LLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0186
|
| Withdraw new drug application (NDA 21-179) for Renagel Tablets (sevelamer hydrochloride) 400 and 800 mg
|
| |
|
|
| EC 2
|
| Mr. Dave Lowe
|
| Vol #:
|
| 1
|
| |
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| 2006P-0223
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| Switch Plan B and equivalent EC drugs from prescription-only to OTC status without age restrictions, exempt from prescription -dispensing requirement any new drug eligible for
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|
| | | | | | | | |
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| |
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| filing an ANDA
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| EC 580
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| Mr. Glen Stremel
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| Vol #:
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| 5
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| |
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| EC 581
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| Mr. David Knebelsberger
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| Vol #:
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| 5
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| |
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| EC 582
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| Dr. theresa mccall
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| Vol #:
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| 5
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| |
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| EC 583
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| Dr. Larissa Meyer
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| Vol #:
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| 5
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| |
|
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| EC 584
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| Mr. Michael Falcone
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| Vol #:
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| 5
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| |
|
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| EC 585
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| Mrs. Susan Calhoun
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| Vol #:
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| 5
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| |
|
|
| EC 586
|
| Mr. Steve Bowman
|
| Vol #:
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| 5
|
| |
|
|
| 2006P-0310
|
| Compel the Agency to follow requirements of the Drug Listing Act of 1972
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| |
|
|
| EC 1
|
| Mr. Dave Lowe
|
| Vol #:
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| 1
|
| |
|
|
| 2006P-0346
|
| Ban Marketing of Estratest, Estratest H.S. and Syntest D.S. and Syntest H.S. associated with Menopause
|
| |
|
|
| EC 1
|
| Mr. Dave Lowe
|
| Vol #:
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| 1
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| |
|
|
| 2006P-0360
|
| Determine that the discontinued formulation of Carbocaine Injection, 3% supplied in 1.8 mL cartridge was not discontinued for safety and efficacy reasons
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| |
|
|
| EC 2
|
| Mr. Dave Lowe
|
| Vol #:
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| 1
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|
| |
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| 2006P-0364
|
| Reformulation of central nervous system (CNS) stimulant drugs
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| |
|
|
| EC 1
|
| Mr. Dave Lowe
|
| Vol #:
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| 1
|
| |
|
|
| 2006P-0365
|
| Citizen Petition Urging FDA to Take Regulatory Action to Safeguard the Public from Violative Dental Devices Distributed by Five Companies, Including Devices Manufactured in Unregistered Facilities and
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| |
|
|
| ACK 1
|
| FDA/DDM to Kerr Corporation
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| Vol #:
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| 1
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| |
|
|
| CP 1
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| Kerr Corporation
|
| Vol #:
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| 1
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|
