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| Dockets Entered
On August 15, 2006
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutrition
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| 1998V-0511
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| Laser Light Show, Fortress Band Show
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| 2002D-0018
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| Race and Ethnicity Data in Clinical Trials for FDA
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| 2006N-0292
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| Unique Device Identification
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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-0178
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| Immediately ban fluoroquinolone antibiotic gatifloxacin in humans
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| 2006P-0196
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| ANDA for Lithium Carbonate Tablets, 300 mg (NDA 016834)
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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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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 18039
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| Neways International
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| Vol #:
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| 166
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| LET 18040
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| New Centruy Company
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| Vol #:
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| 166
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| LET 18041
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| Northwest Natural Products (NNP)
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| Vol #:
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| 166
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| LET 18042
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| Nutrition Now Inc
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| Vol #:
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| 166
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| LET 18043
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| Pharmavite LLC
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| Vol #:
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| 166
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| LET 18044
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| Imagenetix Inc
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| Vol #:
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| 166
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| LET 18045
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| Natrol Inc
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| Vol #:
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| 166
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| 1998N-0359
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| Program priorities/Center for Food Safety & Applied Nutrition
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| EC 395
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| Council for Responsible Nutrition
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| Vol #:
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| 9
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| 1998V-0511
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| Laser Light Show, Fortress Band Show
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| VRA 3
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| FDA/CDRH to Dennis L Myers
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| Vol #:
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| 1
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| 2002D-0018
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| Race and Ethnicity Data in Clinical Trials for FDA
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| EC 9
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| Ms. Frances Smith
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| Vol #:
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| 2
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| 2005D-0103
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| Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials
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| EC 10
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| University Health Network
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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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| CS 16
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| FDA/DDM
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| Vol #:
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| 6
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| OR 16
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| FDA/Administrative law Judge
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| Vol #:
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| 6
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| 2006D-0191
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| Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
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| EC 8
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| Y-ME National Breast Cancer Organization
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| Vol #:
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| 1
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| EC 9
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| Y-ME National Breast Cancer Organization
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| Vol #:
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| 1
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| 2006N-0292
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| Unique Device Identification
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| EC 1
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| Clemson University, Clemson, SC
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| Vol #:
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| 1
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| EC 2
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| Oridion medical 1987 Ltd.
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| Vol #:
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| 1
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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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| EC 697
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| Alliance for Justice
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| Vol #:
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| 3
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| EC 698
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| WOMEN UNDER STUDY
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| Vol #:
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| 3
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| EC 699
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| Mrs. Carolyn Wolf
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| Vol #:
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| 3
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| EC 700
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| Ms. Carol Cloud
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| Vol #:
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| 3
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| EC 701
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| Ms. Dianna McClan
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| Vol #:
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| 3
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| EC 702
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| Mrs. Margaret Galloway
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| Vol #:
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| 3
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| EC 703
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| Mrs. Debra Roundy
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| Vol #:
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| 3
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| EC 704
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| Ms. Jussta Jussta
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| Vol #:
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| 3
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| EC 705
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| National Women's Health Network
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| Vol #:
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| 3
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| EC 706
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| National Women's Health Network
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| Vol #:
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| 3
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| 2006P-0178
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| Immediately ban fluoroquinolone antibiotic gatifloxacin in humans
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| EC 3
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| Ms. Sarah Smith
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| Vol #:
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| 1
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| 2006P-0196
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| ANDA for Lithium Carbonate Tablets, 300 mg (NDA 016834)
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| WDL 1
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| West-ward Pharmaceutical Corp.
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| Vol #:
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| 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 filing an ANDA
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| C 3
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| J Berry
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| Vol #:
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| 1
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