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| Dockets Entered
On August 18, 2006
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| Docket #
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| Title
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| 2001E-0095
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| Vinci System, Patent Extension Application No.5,808,665
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| 2006D-0138
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| Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims
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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-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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| 2001E-0095
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| Vinci System, Patent Extension Application No.5,808,665
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| LET 3
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| Intutitve Surgical, Inc.
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| Vol #:
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| 1
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC 18
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| Mr. Patrick Thomas
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| 6
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| EMC 7
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| Tap Resources
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| 3
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| 2006D-0138
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| Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims
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| EMC 2
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| Animal Health Institute
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| 1
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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 11
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| Cytel Inc.
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| 1
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| 2006N-0292
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| Unique Device Identification
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| EC 5
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| Directed Light
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| 1
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| EC 6
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| Bilanx Consulting LLC
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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 709
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| Mr. Jack David Marcus
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| 3
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| EC 710
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| Ms. Carolann Peters
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| 3
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| EC 711
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| Mrs. Cheryl Taylor
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| Vol #:
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| 3
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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 1
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| Mrs. Tammera Goley
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| Vol #:
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| 3
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| EC 2
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| Miss. Kristie Tousinau
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| 3
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| EC 3
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| Mrs. Cindi Grove
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| Vol #:
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| 3
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| EC 4
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| Dr. D. Dean Goodfellow
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| Vol #:
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| 3
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