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| Dockets Entered
On September 15, 2006
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| Docket #
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| Title
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| 1995N-0309
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| CGMPs for the Production of Infant Formula
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| 1998C-0790
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| Safe use of Synthetic Iron Oxide and Mica-based Pearlescent Pigments
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| 1998E-0613
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| Synvisc Hylan G_F20 Patent No. 5,143,724
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| 2000E-1239
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| Patent Extension Rapamune (sirolimus), #5,100,899
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| 2000E-1402
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| Patent Extension for Betaxon, No. 4,911,920
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| 2001E-0097
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| ReFacto, Patent Extension Application No. 4,868,112
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| 2001E-0099
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| Menicon Z Rigid Contact Lens, Patent Extension Application
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| 2001E-0229
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| Patent Term Extension Application, PAYLEAN No. 4,690,951
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| 2001E-0419
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| Patent Term Extension Application, Precedex No. 4,910,214
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| 2002E-0344
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| Patent Term Application for ATS Open Pivot Bileaf Valve 5,35, U.S. Patent No. 5,354,330
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| 2003E-0035
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| Patent Term Extension Application for ZETIA No. RE37,721
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| 2003E-0410
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| Patent Term Restoration Application for Zubrin (tepoxalin), U.S. Patent No. 4,826,868
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| 2003E-0411
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| Patent Term Restoration Application for Facitive (gemifloxacin mesylate), U.S. Patent No. 5,633, 262
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| 2003E-0416
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| Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353
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| 2003E-0448
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| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,776,944
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| 2003E-0449
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| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,962,468
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| 2003E-0452
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| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
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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-0051
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| Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation
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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-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-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-0271
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| Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI.
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| 2006P-0348
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| Amend the vancomycin HCl package insert to reflect modifications of the antimicrobial susceptibility interpretive criteria to better recognize emerging resistance resulting in compromised patient outc
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| 2006P-0387
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| Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA.
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| 1995N-0309
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| CGMPs for the Production of Infant Formula
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| C 27
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| SHS International Ltd.
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| Vol #:
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| 9
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| C 28
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| PBM Nutritionals, LLC
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| Vol #:
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| 9
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| C 29
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| International Formula Council (IFC)
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| Vol #:
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| 9
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| 1998C-0790
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| Safe use of Synthetic Iron Oxide and Mica-based Pearlescent Pigments
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| NCD 1
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| FDA
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| Vol #:
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| 1
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| 1998E-0613
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| Synvisc Hylan G_F20 Patent No. 5,143,724
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| CEP 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2000E-1239
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| Patent Extension Rapamune (sirolimus), #5,100,899
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| CEP 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2000E-1402
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| Patent Extension for Betaxon, No. 4,911,920
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| CEP 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2001E-0097
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| ReFacto, Patent Extension Application No. 4,868,112
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| AAV 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2001E-0099
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| Menicon Z Rigid Contact Lens, Patent Extension Application
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| CEP 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2001E-0229
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| Patent Term Extension Application, PAYLEAN No. 4,690,951
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| CEP 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2001E-0419
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| Patent Term Extension Application, Precedex No. 4,910,214
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| CEP 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2002E-0344
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| Patent Term Application for ATS Open Pivot Bileaf Valve 5,35, U.S. Patent No. 5,354,330
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| CEP 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0035
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| Patent Term Extension Application for ZETIA No. RE37,721
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| CEP 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0410
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| Patent Term Restoration Application for Zubrin (tepoxalin), U.S. Patent No. 4,826,868
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| CEP 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0411
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| Patent Term Restoration Application for Facitive (gemifloxacin mesylate), U.S. Patent No. 5,633, 262
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| WDL 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0416
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| Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353
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| CEP 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0448
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| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,776,944
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| CEP 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0449
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| Patent Extension for FACTIVE, gemifloxacin mesylate, #5,962,468
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| WDL 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2003E-0452
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| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
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| CEP 1
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| U.S. Patent and Trademark Office
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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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| C 1
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| American Life League, Inc. (ALL)
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| Vol #:
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| 1
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| EC 14
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| Mr. David Thiel
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| Vol #:
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| 1
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| EC 15
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| Johns Hopkins University School of Medicine
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| Vol #:
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| 1
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| 2006N-0051
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| Blood Vessels Recovered with Organs and Intended for Use in Organ Transplantation
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| NWL 1
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| FDA
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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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| TS 1
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| PA Coalition for Mercury-Free Dentistry
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| Vol #:
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| 1
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| TS 2
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| Univeristy of COnnecticut
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| Vol #:
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| 1
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| TS 3
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| L. Brocato
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| Vol #:
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| 1
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| TS 4
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| S. Markus, DDS
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| Vol #:
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| 1
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| TS 5
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| F. Liao, M.A.G.D., A.B.G.D.
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| Vol #:
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| 1
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| TS 6
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| Office of Science and Health Coordination
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| Vol #:
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| 1
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| TS 7
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| P. Burke
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| Vol #:
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| 1
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| TS 8
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| Delta Dental Plans Association (delta Dental)
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| Vol #:
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| 1
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| TS 9
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| American Association of Public Health Dentistry
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| Vol #:
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| 1
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| TS 10
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| A. Kilmartin
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| Vol #:
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| 1
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| TS 11
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| Dr. H. Huggins
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| Vol #:
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| 1
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| TS 12
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| American Dental Education Association and the American Association for Dental Research
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| Vol #:
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| 1
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| TS 13
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| American Dental Association (ADA)
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| Vol #:
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| 1
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| TS 14
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| University of Kentucky
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| Vol #:
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| 1
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| TS 15
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| D. Madronero
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| Vol #:
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| 1
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| TS 16
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| J. Wehrle
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| Vol #:
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| 1
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| TS 17
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| F. Koss
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| Vol #:
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| 1
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| TS 18
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| Honorable Diane E. Watson
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| Vol #:
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| 1
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| TS 19
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| California Dental Association
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| Vol #:
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| 1
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| TS 20
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| DAMS, Intl
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| Vol #:
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| 1
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| TS 21
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| S. Hines
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| Vol #:
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| 1
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| TS 22
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| Academy of General Dentistry (AGD)
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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 721
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| NOW
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| Vol #:
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| 3
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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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| EC 2
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| McNeil Nutritionals, LLC
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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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| EC 697
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| Mr. Todd Merz
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| Vol #:
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| 5
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| EC 698
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| Mrs. Wendy Crespo
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| Vol #:
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| 5
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| EC 699
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| Ms. Theresa Knecht
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| Vol #:
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| 5
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| 2006P-0271
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| Amend practice of assessing the performance of medical devices for determining in vitro susceptibility of bacteria or fungi to included CLSI.
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| EC 1
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| Infectious Diseases Society of America
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| Vol #:
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| 2
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| 2006P-0348
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| Amend the vancomycin HCl package insert to reflect modifications of the antimicrobial susceptibility interpretive criteria to better recognize emerging resistance resulting in compromised patient outc
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| EC 2
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| Infectious Diseases Society of America
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| Vol #:
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| 2
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| 2006P-0387
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| Declare That Clobetasol Propionate from, 0.05% is suitable for submission in an ANDA.
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| ACK 1
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| FDA /DDM to Paddock Laboratories
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| Vol #:
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| 1
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| CP 1
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| Paddock Laboratories
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| Vol #:
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| 1
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