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| Dockets Entered On November 21, 2006
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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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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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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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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| 2004E-0040
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| Patent Extension for CYDECTIN, U.S. Patent No. 4,916,154
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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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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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| 2006D-0303
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| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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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-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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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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| 2006D-0463
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| Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability
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| 2006F-0409
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| Safe Use of Cetylpyridinium Chloride as an Antimicrobial Agent in a Pre-chiller or Post-chiller Solution for Application to Raw Poultry Carcasses (FAP 6A4767)
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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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| 2006N-0414
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| Suicidality Data from Adult Antidepressant Trials
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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-0085
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| To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements
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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-0218
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| To permit an abbrevation New Drug Application Triamcinolone Diacetate Suspension
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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-0224
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| Take appropriate remedial action against the apparent misbranding of generic azithromycin marketed by Pliva, Inc.
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 1978N-0065
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| Skin Bleaching Drug Products
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| C 27
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| Skinsmart Dermatology
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| Vol #:
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| 15
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| C 28
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| Academic Alliance in Dermatology Associates & Affiliates in Dermatology
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| Vol #:
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| 15
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| C 29
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| American Society for Dermatologic Surgery (ASDS)
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| Vol #:
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| 15
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| C 30
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| Van Dyke Laser & Skin
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| Vol #:
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| 15
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| C 31
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| E. Perez, MD, PhD
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| Vol #:
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| 15
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| EC 84
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| Dr. Keith Lopatka
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| Vol #:
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| 14
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| EC 85
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| Dermatology Associates of Northeast Georgia
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| Vol #:
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| 14
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| EC 86
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| Dr. David Byrne
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| Vol #:
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| 14
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| EC 87
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| Calkin Boudreaux Dermatology Associates
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| Vol #:
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| 14
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| EC 88
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| Dr. Michelle Pipitone
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| Vol #:
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| 14
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| LET 909
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| FDA/CFSAN to Alpine Confections Inc
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| Vol #:
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| 27
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| LET 910
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| FDA/CFSAN to Natural Organics Inc
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| Vol #:
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| 27
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 660
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| J. Johnson
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| Vol #:
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| 24
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 741
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| K. Lynn
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| Vol #:
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| 10
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| 2003D-0478
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| Guidance on Marketed Unapproved Drugs Compliance Policy Guide
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| C 70
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| Peiser & Associates, Inc.
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| Vol #:
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| 5
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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 1385
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| D. Wright
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| Vol #:
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| 12
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| 2004D-0002
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| Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
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| GDL 2
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| Guidance
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| Vol #:
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| 2
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| NAD 2
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| FDA
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| Vol #:
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| 2
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| 2004E-0040
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| Patent Extension for CYDECTIN, U.S. Patent No. 4,916,154
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| EXP 1
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| Wyeth Holdings Corporation
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| Vol #:
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| 1
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| 2005N-0403
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| Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
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| C 3
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| Tap Pharmaceutical Products, Inc.
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| Vol #:
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| 3
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| EMC 3
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| Becton, Dickinson & Company
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| Vol #:
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| 3
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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 4126
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| J. Hamlin
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| Vol #:
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| 195
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| EMC 4127
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| J. Hamlin
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| Vol #:
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| 195
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| EMC 4128
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| D. Stone
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| Vol #:
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| 195
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| EMC 4129
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| J. Weiler
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| Vol #:
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| 195
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| EMC 4130
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| G. Decesare
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| Vol #:
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| 195
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| EMC 4131
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| D. Miller
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| Vol #:
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| 195
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| EMC 4132
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| C. Matchett
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| Vol #:
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| 195
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| EMC 4133
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| A. Hrdlicka
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| Vol #:
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| 195
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| EMC 4134
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| E. Finn
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| Vol #:
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| 195
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| EMC 4135
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| C. Woods
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| Vol #:
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| 195
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| EMC 4136
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| R. Blair
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| Vol #:
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| 195
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| EMC 4137
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| B. Day
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| Vol #:
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| 195
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| EMC 4138
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| K. Pierce
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| Vol #:
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| 195
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| EMC 4139
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| R. Peterson
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| Vol #:
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| 195
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| EMC 4140
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| R. Wildfong
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| Vol #:
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| 195
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| EMC 4141
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| J. Serra
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| Vol #:
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| 195
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| EMC 4142
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| C. Azzarone
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| Vol #:
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| 195
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| EMC 4143
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| J. Sheeler-Shenk
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| Vol #:
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| 195
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| EMC 4144
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| M. Rubin
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| Vol #:
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| 195
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| RC 3
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| Kalsec, Inc.
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| Vol #:
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| 7
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| 2006D-0303
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| Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
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| C 5
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| Wyeth Pharmaceuticals
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| Vol #:
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| 1
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| EC 1
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| sanofi-aventis
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| Vol #:
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| 1
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| EC 2
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| Novo Nordisk Inc
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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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| EC 58
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| Dana-Farber Cancer Institute
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| Vol #:
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| 3
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| C 1
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| Mayo Clinical Trial Services
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| Vol #:
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| 1
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| EC 9
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| Genomic Health, Inc.
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| Vol #:
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| 1
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| EC 10
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| Public Health Genetics Unit
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| Vol #:
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| 1
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| EXT 1
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| Aureon Laboratories, Inc.
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| Vol #:
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| 1
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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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| C 107
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| A. O'Halloran, M.D.
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| Vol #:
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| 9
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| C 108
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| L. Sosa
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| Vol #:
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| 9
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| C 109
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| S. Stewart
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| Vol #:
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| 9
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| C 110
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| C. Sodowsky, RN
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| Vol #:
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| 9
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| C 111
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| D. Benedict
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| Vol #:
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| 9
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| C 112
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| B. Rose, RN, MSN, FCP
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| Vol #:
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| 9
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| C 113
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| Dr. D. Perrella
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| Vol #:
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| 9
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| C 114
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| P. Velez
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| Vol #:
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| 9
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| C 115
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| Women Health Collaborative
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| Vol #:
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| 9
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| EC 2016
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| Mrs. Marian O'Brien-Frigo
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| Vol #:
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| 8
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| EC 2017
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| Mr. Paul Rozeski
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| Vol #:
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| 8
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| EC 2018
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| Mrs. Anna Thompson
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| Vol #:
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| 8
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| EC 2019
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| Mr. Paul Mraz
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| Vol #:
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| 8
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| EC 2020
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| Mrs. Lisa Guernsey
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| Vol #:
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| 8
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| EC 2021
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| Mrs. maureen levri
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| Vol #:
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| 8
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| EC 2022
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| St. John the Beloved Catholic Church
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| Vol #:
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| 8
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| EC 2023
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| Mrs. Ann Metzger
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| Vol #:
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| 8
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| 2006D-0463
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| Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2006F-0409
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| Safe Use of Cetylpyridinium Chloride as an Antimicrobial Agent in a Pre-chiller or Post-chiller Solution for Application to Raw Poultry Carcasses (FAP 6A4767)
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| EC 2
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| Ecolab Inc.
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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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| EMC 1143
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| M. Kiefer
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| Vol #:
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| 24
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| EMC 1144
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| W. Webb
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| Vol #:
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| 24
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| 2006N-0414
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| Suicidality Data from Adult Antidepressant Trials
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| C 1
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| H. Patenaude
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| Vol #:
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| 1
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|
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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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|
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| NHC 1
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| FDA
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| Vol #:
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| 1
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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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| C 5
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| Nouveau Prosthetics and Orthotics
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| Vol #:
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| 2
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| C 6
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| Nouveau Prosthetics and Orthotics
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| Vol #:
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| 2
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| C 7
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| Permanente Medical Group
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| Vol #:
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| 2
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| C 8
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| Orhotics Choice (OC)
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| Vol #:
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| 2
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| C 9
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| American Orthotic & Prosthetic Association (AOPA)
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| Vol #:
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| 2
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| EC 6
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| American Association of Neurological Surgeons/Cong
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| Vol #:
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| 1
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| EC 7
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| Rainbow Babies and Childrens Hospital
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| Vol #:
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| 1
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|
|
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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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|
|
|
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| PDN 1
|
| FDA/CDRH to Chemically Associated Neurological Disorders
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| Vol #:
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| 1
|
|
|
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| 2006P-0218
|
| To permit an abbrevation New Drug Application Triamcinolone Diacetate Suspension
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| LET 1
|
| FDA/CDER to West-ward Pharmaceutical Corp.
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| Vol #:
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| 1
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