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Dockets Management
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| Dockets Entered
On August 7, 2006
Table of Contents
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| Docket #
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| Title
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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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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| 2003N-0355
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| Medical Devices; Exception from General Requirements for Informed Consent
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| 2004E-0308
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| Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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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-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| 2006E-0025
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| Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
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| 2006E-0026
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| Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639
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| 2006E-0043
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| Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,529,990
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| 2006N-0202
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2006P-0070
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| Misbranding of generic azithromycin products marketed by Teva Pharmaceuticals USA and Sandoz Inc.
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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-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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| 2006P-0309
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| ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
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| 2006P-0310
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| Compel the Agency to follow requirements of the Drug Listing Act of 1972
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| 2006P-0311
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| Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| RPT 769
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| Statistical Report - Month of July 2006
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| Vol #:
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| 55
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4415
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| B. Payack
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| Vol #:
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| 320
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| EMC 4416
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| A. McLean
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| Vol #:
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| 320
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| EMC 4417
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| I. Negroni
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| Vol #:
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| 320
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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 17
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| CJD WATCH
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| Vol #:
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| 6
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| 2003N-0355
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| Medical Devices; Exception from General Requirements for Informed Consent
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| EC 7
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| Association of Public Health Laboratories
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| Vol #:
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| 1
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| 2004E-0308
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| Patent Extension for RESTYLANE Injectable Gel (Polysaccharide Gel Composition), U.S. Patent No. 5,827,937
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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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| 2004N-0226
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| Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
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| EC 16
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| Mrs. Elizabeth Grey
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| Vol #:
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| 1
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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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| C 17995
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| N. Wheel
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| Vol #:
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| 194
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| C 17996
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| C. Rose
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| Vol #:
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| 194
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| C 17997
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| E. Hobbs
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| Vol #:
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| 194
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| C 17998
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| E. Peet
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| Vol #:
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| 184
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| C 17999
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| S. Scheinfeld
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| Vol #:
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| 194
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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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| C 7
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| Kansas State University
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| Vol #:
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| 2
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| 2006D-0226
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| Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203; Effective Date and Compliance Policy GuideProgram, Draft Guidance; Availability
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| C 4
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| PSS World Medical, Inc. (PSSI)
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| Vol #:
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| 1
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| 2006E-0025
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| Patent Extension Application for INCRELEX (mecasermin rDNA orgin injection), U.S. Patent No. 5,681,814
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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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| 2006E-0026
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| Patent Extension Application for Luveris (recombinant human luteinizing hormone), U.S. Patent No. 5,639,639
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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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| 2006E-0043
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| Patent Extension Application for TYGACIL (tigecycline), U.S. Patent No. 5,529,990
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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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| 2006N-0202
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| EMC 1
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| Canadian Food Inspection Agency
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| Vol #:
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| 2
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| 2006P-0070
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| Misbranding of generic azithromycin products marketed by Teva Pharmaceuticals USA and Sandoz Inc.
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| LET 1
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| FDA/CDER to Pfizer, Inc.
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| Vol #:
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| 2
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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 684
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| The Links, Inc.
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| Vol #:
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| 3
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| EC 685
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| Ms. Geri Marshall
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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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| EMC 30
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| K. Foote
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| Vol #:
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| 1
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| EMC 31
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| K. Russell
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| Vol #:
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| 1
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| EMC 32
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| A. Sheldon
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| Vol #:
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| 1
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| EMC 33
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| A. Swalve
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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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| C 1
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| D. Lowe
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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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| EMC 1
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| V. Longanecker
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| Vol #:
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| 2
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| EMC 2
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| W. Depner
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| Vol #:
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| 2
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| EMC 3
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| S. Stephens
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| Vol #:
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| 2
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| EMC 4
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| P. Webb
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| Vol #:
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| 2
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| EMC 5
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| V. Longanecker
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| Vol #:
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| 2
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| EMC 6
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| D. Edwards
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| Vol #:
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| 2
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| EMC 7
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| D. & M. Gartner
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| Vol #:
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| 2
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| EMC 8
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| J. Berry
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| Vol #:
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| 2
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| EMC 9
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| J. McDonough
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| Vol #:
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| 2
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| EMC 10
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| G. Spinelli
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| Vol #:
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| 2
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| EMC 11
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| T. Schultz
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| Vol #:
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| 2
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| EMC 12
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| J. Carducci
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| Vol #:
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| 2
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| EMC 13
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| J. Carducci
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| Vol #:
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| 2
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| EMC 14
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| J. Carducci
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| Vol #:
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| 2
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| EMC 15
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| M. McHugh
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| Vol #:
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| 2
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| EMC 16
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| F. & M. Parente
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| Vol #:
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| 2
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| EMC 17
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| R. Clark
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| Vol #:
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| 2
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| EMC 18
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| C. Holguin
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| Vol #:
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| 2
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| EMC 19
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| B. Svirbel
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| Vol #:
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| 2
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| EMC 20
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| K. Herpak
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| Vol #:
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| 2
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| EMC 21
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| M. Datovech
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| Vol #:
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| 2
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| EMC 22
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| G. Samples
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| Vol #:
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| 2
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| 2006P-0309
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| ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
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| ACK 1
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| FDA/DDMB to Frommer, Lawrence & Haug, LLP
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| Vol #:
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| 1
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| CP 1
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| Frommer, Lawrence & Haug, LLP
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| Vol #:
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| 1
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| 2006P-0310
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| Compel the Agency to follow requirements of the Drug Listing Act of 1972
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| ACK 1
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| FDA/DDM to Peiser & Associates Inc.
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| Vol #:
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| 1
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| CP 1
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| Peiser & Associates Inc.
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| Vol #:
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| 1
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