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| Dockets Entered
On June 7, 2007
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| Docket #
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| Title
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| 1979P-0055
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| Avi Laserlumia
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998D-1232
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| Points to consider guidance documents on assayed&unassayed
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| 2000V-1247
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| Laser Light Show
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| 2001P-0230
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| Domestic Marketing & Importation of Transgenic Fish
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004D-0466
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| Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
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| 2004P-0183
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| Nutrient Content Claim: Expand Lean Definition
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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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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| 2006D-0363
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| Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Absorbable Hemostatic Device
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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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| 2006N-0362
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| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
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| 2006P-0201
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| Cefotan (cefotetan injection), equivalent 1 g base/vial and 2 g base/vial, mfged by AstraZeneca has been voluntarily withdrawn from sale for safety and efficacy reasons
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| 2006P-0496
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| Determine whether Sulfamethoxazole, Trimethoprim, and Phenazopyride HCI, have been voluntarily withdrawn or withheld for safety or efficacy reasons
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| 2006P-0508
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| Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
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| 2007D-0080
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| Guidance for Industry on Indexing Structured Product Labeling
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| 2007D-0083
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| Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
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| 2007D-0106
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| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| 2007D-0122
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems
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| 2007D-0212
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| Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis
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| 2007E-0010
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| Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
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| 2007M-0006
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| P050037 - Radiesse, 1.3cc and 0.3cc
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| 2007M-0007
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| P050052 - Radiesse, 1.3cc and 0.3cc
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| 2007M-0032
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| P050018 - AngioSculpt Scoring Balloon Catheter
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| 2007M-0038
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| Fujirebio Mesomark Assay
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| 2007M-0049
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| P060001 - Protg and Protg RX Carotid Stent Systems
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| 2007M-0058
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| P050007/S001 - StarClose Vascular Closure System, Model 1004, Version 2.10
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| 2007M-0084
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| P050053 - InFuse Bone Graft
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| 2007M-0086
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| P050013 - Histoacryl and Histoacryl Blue Topical Skin Adhesive
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| 2007M-0107
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| P980022/S015 - Guardian REAL-Time and Paradigm REAL-Time Systems
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| 2007M-0109
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| P040051 - Stelkast Surpass Acetabular System
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| 2007N-0053
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| EC 295
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| Mr. Tommy Brue
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| Vol #:
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| 6
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| EC 296
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| American Veterinary Medical Association
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| Vol #:
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| 6
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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 18312
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| J. Solano
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| Vol #:
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| 198
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| C 18313
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| P. Solano
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| Vol #:
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| 198
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| C 18314
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| S. Stevens
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| Vol #:
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| 198
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| 2006D-0363
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| Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Absorbable Hemostatic Device
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| C 5
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| HemCon Medical Technologies Inc (HemCon)
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| Vol #:
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| 1
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| C 6
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| HemCon Medical Technologies Inc (HemCon)
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| Vol #:
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| 1
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| C 7
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| Ethicon Inc
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| Vol #:
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| 1
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| C 8
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| Ferrosan A/S
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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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| SS 1
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| Supporting Statement
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| Vol #:
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| 1
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| 2006N-0362
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| General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
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| C 18
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| Ferrosan A/S
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| 1
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| C 19
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| HemCon Medical Technologies Inc (HemCon)
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| Vol #:
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| 1
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| C 20
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| Oakwood Hospital & Medical Cente
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| Vol #:
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| 1
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| C 21
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| Vascular & Transplant Specialists
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| Vol #:
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| 1
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| C 22
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| HemCon Medical Technologies
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| Vol #:
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| 1
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| C 23
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| University of California, Los Angeles
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| Vol #:
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| 1
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| C 24
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| Carolina NeutroSurgery & Spine Associates
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| Vol #:
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| 1
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| C 25
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| Ethicon Inc
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| Vol #:
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| 1
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| C 26
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| University of Virginia Health System, Department of Neurological Surgery
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| Vol #:
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| 1
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| EC 3
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| Z-Medica Corporation
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| Vol #:
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| 1
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| 2006P-0201
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| Cefotan (cefotetan injection), equivalent 1 g base/vial and 2 g base/vial, mfged by AstraZeneca has been voluntarily withdrawn from sale for safety and efficacy reasons
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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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| 2006P-0496
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| Determine whether Sulfamethoxazole, Trimethoprim, and Phenazopyride HCI, have been voluntarily withdrawn or withheld for safety or efficacy reasons
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| LET 1
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| FDA/CDER to Vintage Pharmaceuticals LLC
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| Vol #:
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| 1
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| 2006P-0508
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| Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
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| LET 1
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| FDA/CDER to C Weber
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| Vol #:
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| 1
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| 2007D-0080
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| Guidance for Industry on Indexing Structured Product Labeling
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| C 1
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| Bristol-Myers Squibb Company
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| Vol #:
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| 1
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| 2007D-0083
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| Guidance for Industry and Food and Drug Administration Staff; Modifications to Devices Subject to Premarket Approval (PMA) Applications The PMA Supplement Decision Making Process
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| C 1
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| ElA Medical Inc
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| Vol #:
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| 1
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| 2007D-0106
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| Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting Improving Human Subject Protection
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| C 2
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| Bristol-Myers Squibb Company
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| Vol #:
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| 1
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| EC 8
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| Association of American Medical Colleges
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| Vol #:
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| 1
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| C 2
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| Eurand Inc
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| Vol #:
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| 1
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| EC 5
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| GlaxoSmithKline
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| Vol #:
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| 1
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| 2007D-0122
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems
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| EC 1
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| Mrs. Deborah Newfield
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| Vol #:
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| 1
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| 2007D-0212
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| Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis
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| GDL 1
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| Guidance
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| Vol #:
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| 1
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| NAD 1
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| FDA
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| Vol #:
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| 1
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| 2007E-0010
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| Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
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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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| 2007M-0006
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| P050037 - Radiesse, 1.3cc and 0.3cc
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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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| 2007M-0007
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| P050052 - Radiesse, 1.3cc and 0.3cc
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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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| 2007M-0032
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| P050018 - AngioSculpt Scoring Balloon Catheter
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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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| 2007M-0038
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| Fujirebio Mesomark Assay
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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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| 2007M-0049
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| P060001 - Protg and Protg RX Carotid Stent Systems
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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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| 2007M-0058
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| P050007/S001 - StarClose Vascular Closure System, Model 1004, Version 2.10
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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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| 2007M-0084
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| P050053 - InFuse Bone Graft
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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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| |
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| 2007M-0086
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| P050013 - Histoacryl and Histoacryl Blue Topical Skin Adhesive
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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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| 2007M-0107
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| P980022/S015 - Guardian REAL-Time and Paradigm REAL-Time Systems
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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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| 2007M-0109
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| P040051 - Stelkast Surpass Acetabular 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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| NAL 2
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| FDA
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| Vol #:
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| 1
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| 2007N-0053
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations
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| EC 2
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| Mrs. Barbara Susco
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| Vol #:
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| 1
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| 2007N-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| EAPE 256
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| Nelson, Susan
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| Vol #:
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| 7
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| EAPE 257
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| Fava, Jamie
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| Vol #:
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| 7
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| EAPE 258
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| Hall, Stacia
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| Vol #:
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| 7
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| EAPE 259
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| Ptakowski, Kristin
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| Vol #:
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| 7
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| EAPE 260
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| Horn, Donna
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| Vol #:
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| 7
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| EAPE 261
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| Baker, Erin
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| Vol #:
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| 7
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| EAPE 262
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| Espie , S. Denise
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| Vol #:
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| 7
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| EAPE 263
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| bonnel, renan
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| Vol #:
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| 7
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| EAPE 264
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| Robinson, Sally
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| Vol #:
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| 7
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| EAPE 265
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| Griffis, Terry
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| Vol #:
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| 7
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| |
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| 2007N-0208
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| Interim Melamine and Melamine Analogues Safety/Risk Assessment; Availability
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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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| 2007V-0222
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| Projector for a Laser Light Show
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| ACK 1
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| FDA /DDM to Tempest International LLC
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| Vol #:
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| 1
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| VAR 1
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| Tempest International LLC
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| Vol #:
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| 1
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