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| Dockets Entered
On November 1, 2006
Table of Contents
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| Docket #
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| Title
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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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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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| 2004P-0349
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| Action on Products containing added Mercury
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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-0296
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex on Residue on Ignition/Sulphated Ash General Chapter;
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| 2006D-0297
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
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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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| 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-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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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-0085
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| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
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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-0178
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| Immediately ban fluoroquinolone antibiotic gatifloxacin in humans
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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-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0438
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| ANDA for Betamethasone Valerate Foam (non-aerosol), 0.12%
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| 2006P-0444
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| Stay the potential grant effective approval of ANDA for 77-536 for moexipril hydrochloride tablets
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| 2006P-0445
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| Determine if Mivacron (mivacurium chloride injection) was withdrawn for safety or efficacy reasons
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| 2006P-0446
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| ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg
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| 1988N-0258
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| Prescription Drug Marketing Act of 1987; Guideline
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| C 147
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| Southwood Pharmaceuticals, Inc.
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| Vol #:
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| 8
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| 1992N-0297
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| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
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| C 141
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| Southwood Pharmaceuticals, Inc.
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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 657
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| N. Cruz
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| Vol #:
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| 24
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EC 4
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| Colorado Health Professionals
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| Vol #:
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| 7
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 727
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| Calorie Control Council
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| Vol #:
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| 10
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| EMC 728
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| A. Rogers
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| Vol #:
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| 10
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| EMC 729
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| New York State Coalition Opposed to Fluoridation, Inc.
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| Vol #:
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| 10
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| EMC 730
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| S. Williams-Crosby
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| Vol #:
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| 10
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| EMC 731
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| W. Westfall
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| Vol #:
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| 10
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1367
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| Musiccompulsive
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| Vol #:
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| 12
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| EMC 1368
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| J. Cox
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| Vol #:
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| 12
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| EMC 1369
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| J. See
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| Vol #:
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| 12
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| EMC 1370
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| R. & S. Gilbert
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| Vol #:
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| 12
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| EMC 1371
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| D. Cassidy
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| Vol #:
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| 12
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| EMC 1372
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| P. Boghossian
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| Vol #:
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| 12
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| 2003P-0544
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| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
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| C 68
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| J. Conley
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| Vol #:
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| 5
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| 2004P-0349
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| Action on Products containing added Mercury
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| EC 24
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| Dr. Lisa Siddall
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| Vol #:
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| 4
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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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| EMC 4038
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| D. Lunde
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| Vol #:
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| 195
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| EMC 4039
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| T. Godby-Ware
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| Vol #:
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| 195
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| EMC 4040
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| J. Donovan
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| Vol #:
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| 195
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| EMC 4041
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| T. Deaton
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| Vol #:
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| 195
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| EMC 4042
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| C. James
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| Vol #:
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| 195
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| EMC 4043
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| I. De Las Nieves
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| Vol #:
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| 195
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| EMC 4044
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| D. Wise
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| Vol #:
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| 195
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| EMC 4045
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| R. Sheker
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| Vol #:
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| 195
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| EMC 4046
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| J. Jamme
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| Vol #:
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| 195
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| 2006D-0296
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex on Residue on Ignition/Sulphated Ash General Chapter;
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| C 3
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| Schering-Plough
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| Vol #:
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| 1
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| 2006D-0297
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
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| C 4
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| Schering-Plough
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| Vol #:
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| 1
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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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| | | | | | | | |
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| TR 1
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| Public Hearing on Emergency Research and Human Subject Protections Challenges and Solutions
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| Vol #:
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| 4
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| TS 4
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| University of Maryland School of Medicine
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| Vol #:
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| 3
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| TS 5
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| American Heart Association
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| Vol #:
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| 3
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| TS 6
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| UCLA Stroke Center
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| Vol #:
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| 3
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| TS 7
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| R. Silbergleit, MD
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| Vol #:
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| 3
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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 5
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| Mr. Eric Giunta
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| Vol #:
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| 1
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| EC 6
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| Mrs. Dru Chauffe
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| Vol #:
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| 1
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| EC 7
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| Mrs. Barbara Svatek
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| Vol #:
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| 1
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| EC 8
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| Dr. Christin McIntyre
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| Vol #:
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| 1
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| EC 9
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| Mrs. Christine Lowe
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| Vol #:
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| 1
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| EC 10
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| Mrs. Catherine Williams
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| Vol #:
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| 1
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| EC 11
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| Ms. Trang Nguyen
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| Vol #:
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| 1
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| EC 12
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| Mrs. Sydney Jacobs
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| Vol #:
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| 1
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| EC 13
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| Capano Enterprises, Int'l
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| Vol #:
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| 1
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| EC 14
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| Mr. Aaron Davidsson
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| Vol #:
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| 1
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| EC 22
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| Nutritional Solutions
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| Vol #:
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| 12
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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 137
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| Ms. Kim Rylander
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| Vol #:
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| 3
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| EC 138
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| Dr. Prestor Saillant
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| Vol #:
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| 3
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| EC 139
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| American Dental Association
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| Vol #:
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| 3
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| EC 140
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| Dental Care
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| Vol #:
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| 3
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| EC 141
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| Mr. Nickolas Ziavras
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| Vol #:
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| 3
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| EC 142
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| Ms. Lisa Semle
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| Vol #:
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| 3
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| EC 143
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| health
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| Vol #:
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| 3
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| EC 144
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| Ms. Lisa D-B
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| Vol #:
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| 3
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| EC 145
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| Mrs. Yvonne Gulezian
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| Vol #:
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| 3
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| EC 146
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| Ms. Joanne Cali
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| Vol #:
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| 3
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| EC 147
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| Mrs. Charlene Logsdon
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| Vol #:
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| 3
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| EC 148
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| Mrs. Melissa Hester
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| Vol #:
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| 3
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| EC 149
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| Dr. Stuart Freedenfeld
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| Vol #:
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| 3
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| EC 150
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| Dr. David L Lerner, DDS
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| Vol #:
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| 3
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| EC 151
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| IAOMT
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| Vol #:
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| 3
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| | | | | | | |
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| |
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| EC 152
|
| Ms. Kate Gillis
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| Vol #:
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| 3
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| EC 153
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| Colorado Health Professionals
|
| Vol #:
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| 3
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|
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|
|
| EMC 563
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| C. Maddix
|
| Vol #:
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| 15
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| EMC 564
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| R. Roy
|
| Vol #:
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| 15
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| EMC 565
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| A. M. R. A. M.
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| Vol #:
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| 15
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| EMC 566
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| M. Hartsong
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| Vol #:
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| 15
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| EMC 567
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| L. Brocato
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| Vol #:
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| 15
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| EMC 568
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| K. Harner
|
| Vol #:
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| 15
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| EMC 569
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| Consumers for Dental Choice
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| Vol #:
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| 15
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| EMC 570
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| Consumers for Dental Choice
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| Vol #:
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| 15
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| EMC 571
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| Consumers for Dental Choice
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| Vol #:
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| 15
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| EMC 572
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| Consumers for Dental Choice
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| Vol #:
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| 15
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| EMC 573
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| C. Brown
|
| Vol #:
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| 15
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| EMC 574
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| Consumers for Dental Choice
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| Vol #:
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| 15
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| EMC 575
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| Consumers for Dental Choice
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| Vol #:
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| 15
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| EMC 576
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| C. Brown
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| Vol #:
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| 15
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| EMC 577
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| Consumers for Dental Choice & Coalition for Mercury-Free Dentistry
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| Vol #:
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| 15
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| EMC 578
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| Reeves Law Office
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| Vol #:
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| 15
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| EMC 579
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| S. Kim
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| Vol #:
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| 15
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| EMC 580
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| D. Brimhall
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| Vol #:
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| 15
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| EMC 581
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| D. Rhoades
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| Vol #:
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| 15
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| EMC 582
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| D. Hurowitz
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| Vol #:
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| 15
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| EMC 583
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| N. Oakes
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| Vol #:
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| 15
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| EMC 584
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| Associated Press & Los Angeles Times
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| Vol #:
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| 15
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| EMC 585
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| Roanoke Times
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| Vol #:
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| 15
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| EMC 586
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| FDAWeek
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| Vol #:
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| 15
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| EMC 587
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| Court Reporters & Transcribers
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| Vol #:
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| 15
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| EMC 588
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| Consumers for Dental Choice
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| Vol #:
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| 15
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| EMC 589
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| D. Watson
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| Vol #:
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| 15
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| EMC 590
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| G. Shore
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| Vol #:
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| 15
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| EMC 591
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| M. Block
|
| Vol #:
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| 15
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|
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| EMC 592
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| T. Irvin
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| Vol #:
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| 15
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|
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|
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| EMC 593
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| K. Nelson
|
| Vol #:
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| 15
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| EMC 594
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| B. Sage
|
| Vol #:
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| 15
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|
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|
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| EMC 595
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| W. Webb
|
| Vol #:
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| 15
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|
|
|
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| EMC 596
|
| G. Webb
|
| Vol #:
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| 15
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|
|
|
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| EMC 597
|
| D. Cook
|
| Vol #:
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| 15
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|
| | | | | | | |
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| |
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| EMC 598
|
| Organics America
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 599
|
| D. LaRoux
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 600
|
| Organics America
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 601
|
| Aesthetic Dentistry of Bellevue & Aesthetic Dentistry of Lake Oswego
|
| Vol #:
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| 15
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|
|
|
|
| EMC 602
|
| Aesthetic Dentistry of Bellevue & Aesthetic Dentistry of Lake Oswego
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 603
|
| Aesthetic Dentistry of Bellevue & Aesthetic Dentistry of Lake Oswego
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 604
|
| Z. Valiavicharska
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 605
|
| C. Kahus
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 606
|
| Tawo Seed Carrier
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 607
|
| C. Yokoyama
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 608
|
| G. Marshall
|
| Vol #:
|
| 15
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|
|
|
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| EMC 609
|
| L. Deutsch
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 610
|
| L. Salzer
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 611
|
| P. Kultgen
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 612
|
| The CrossRoads Clinic-Arizona Center for Advanced Medicine & Clinical Research
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 613
|
| Arizona Homeopathic & Integrative Medical Association
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 614
|
| M. Butler
|
| Vol #:
|
| 15
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|
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|
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| EMC 615
|
| M. Thoennes
|
| Vol #:
|
| 15
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|
|
|
|
| EMC 616
|
| Consumers for Dental Choice
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 617
|
| Consumers for Dental Choice
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 618
|
| A. Dattner
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 619
|
| Consumers for Dental Choice
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 620
|
| Office of Congresswomen Diane E. Watson
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 621
|
| Rockland County Conservation Association, Inc.
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 622
|
| E. Shogren
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 623
|
| Consumers for Dental Choice
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 624
|
| A. Swansnon
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 625
|
| C. Maloney
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 626
|
| J. Witherspoon
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 627
|
| C. Smith
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 628
|
| S. Bollinger
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 629
|
| E. Asher
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 630
|
| T. Messerman
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 631
|
| M. Puff
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 632
|
| M. Puff
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 633
|
| Patients Against Mercury Amalgams, U. K.
|
| Vol #:
|
| 15
|
|
|
|
|
| EMC 634
|
| T. Renfro
|
| Vol #:
|
| 15
|
|
| | | | | | | | |
|
| |
|
| Withdraw new drug application (NDA 21-179) for Renagel Tablets (sevelamer hydrochloride) 400 and 800 mg
|
|
|
|
|
| LET 1
|
| FDA/CDER to Charles R. Nolan, M.D
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0223
|
| 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
|
|
|
|
|
|
|
|
|
| EC 711
|
| Mr. david getlin
|
| Vol #:
|
| 5
|
|
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
|
|
| EC 376
|
| Mrs. Heather Harrison-Rouillard
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 377
|
| Mrs. Bonnie Knight
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 378
|
| Ms. Christin Spigai
|
| Vol #:
|
| 7
|
|
|
|
|
| EC 379
|
| Mrs. Margaret Maher
|
| Vol #:
|
| 7
|
|
|
|
|
| 2006P-0438
|
| ANDA for Betamethasone Valerate Foam (non-aerosol), 0.12%
|
|
|
|
|
| C 1
|
| D. Lowe
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0444
|
| Stay the potential grant effective approval of ANDA for 77-536 for moexipril hydrochloride tablets
|
|
|
|
|
| ACK 1
|
| FDA/DDM to Schwarz Pharma, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| PSA 1
|
| Schwarz Pharma, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0445
|
| Determine if Mivacron (mivacurium chloride injection) was withdrawn for safety or efficacy reasons
|
|
|
|
|
| ACK 1
|
| FDA/DDM to Regulus Pharmaceutical Consulting, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| Regulus Pharmaceutical Consulting, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2006P-0446
|
| ANDA for PHENERGAN Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg
|
|
|
|
|
| ACK 1
|
| FDA/DDM to Taro Pharmaceuticals USA, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP 1
|
| Taro Pharmaceuticals USA, Inc.
|
| Vol #:
|
| 1
|
|
