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| Dockets Entered
On September 27, 2006
Table of Contents
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| Docket #
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| Title
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| 2004N-0234
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| Annual Guidance Agenda
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| 2004P-0349
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| Action on Products containing added Mercury
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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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-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| 2006E-0006
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819
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| 2006M-0148
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| P040028 - LUMA Cervical Imaging System
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| 2006M-0161
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| Premarket Approval for Ceralas I Laser System and Ceralink Slit Lamp Adapter by QLT USA, Inc., P050021
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| 2006M-0162
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| Quantel Activis Laser and ZSL30 ACT, and HSBMBQ ACT Slit Lamp Adapters by - QLT USA, Inc.
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| 2006M-0193
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| P040033 - Birmingham Hip Resurfacing (BHR) System
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| 2006M-0199
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| P030008/S004 - WaveLight ALLEGRETTO WAVE Excimer Laser System
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| 2006M-0200
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| P050012 - DexCom STS Continuous Glucose Monitoring System
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| 2006M-0235
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| P050047 - Juvederm 24HV, Juvederm 30, and Juvederm 30HV Gel Implants
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| 2006M-0264
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| Premarket Approval: P040052 -MonoPrep Pap Test (MPPT)
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006N-0283
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| Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
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| 2006P-0124
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| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
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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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| To take regulatory action to revise the labeling requirements for eggs sold in the United States
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| 1995S-0158
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| Community Disclosure of Institutional Review Boards
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| RPT 20
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| University of Texas Health Science Center at San Antonio
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| Vol #:
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| 19
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| 2004N-0234
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| Annual Guidance Agenda
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| EC 4
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| Valley High School
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| Vol #:
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| 1
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| 2004P-0349
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| Action on Products containing added Mercury
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| PDN 1
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| FDA to Coalition for Mercury-free Drugs (CoMeD)
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| Vol #:
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| 1
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| MO 19
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| TMJ Implants, Inc.
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| Vol #:
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| 6
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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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| EC 2
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| Animal Health Institute
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| Vol #:
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| 3
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| | | | | | | | |
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| SUP 17
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| Department of the Planet Earth
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| Vol #:
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| 5
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| 2006E-0006
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2006M-0148
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| P040028 - LUMA Cervical Imaging System
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| 2006M-0161
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| Premarket Approval for Ceralas I Laser System and Ceralink Slit Lamp Adapter by QLT USA, Inc., P050021
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| 2006M-0162
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| Quantel Activis Laser and ZSL30 ACT, and HSBMBQ ACT Slit Lamp Adapters by - QLT USA, Inc.
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| 2006M-0193
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| P040033 - Birmingham Hip Resurfacing (BHR) System
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| 2006M-0199
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| P030008/S004 - WaveLight ALLEGRETTO WAVE Excimer Laser System
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| 2006M-0200
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| P050012 - DexCom STS Continuous Glucose Monitoring System
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| 2006M-0235
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| P050047 - Juvederm 24HV, Juvederm 30, and Juvederm 30HV Gel Implants
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| NAL 1
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| FDA
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| Vol #:
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| 1
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| 2006M-0264
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| Premarket Approval: P040052 -MonoPrep Pap Test (MPPT)
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| NAL 1
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| FDA
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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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| C 4
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| C. Pelsor
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| Vol #:
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| 1
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| C 5
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| R. Knablin
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| Vol #:
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| 1
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| 2006N-0283
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| Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians Perceptions of the Impact of Early Risk Communication about Medical Products
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| C 2
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| Scientific Advantage, LLC
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| Vol #:
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| 1
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| 2006P-0124
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| Stay any approvals of an Abbreviated New Drug Application (ANDA) for Vancocin Capsules
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| SUP 3
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| ViroPharma Incorporated (ViroPharma)
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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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