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| Dockets Entered
On April 3, 2007
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| Docket #
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| Title
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| 1976N-0052G
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| OTC general comments & combinations
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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| |
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| 2004P-0349
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| Action on Products containing added Mercury
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| |
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| 2004P-0522
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| Off label drug use for CYTOTEC
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| |
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| 2005D-0468
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
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| |
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| |
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| 2005N-0262
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| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
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| |
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| |
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| |
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| 2005N-0471
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| Immunology and Microbiology Devices: Reclassification of Herpes Simplex Virus (Types 1 and/or 2) Serological Assays
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| |
|
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| |
|
|
| 2006D-0504
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| Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices
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| |
|
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| 2006M-0396
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| P050038 - Arista AH Absorbable Hemostat
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| |
|
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| 2006M-0411
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| P040027 - GORE VIATORR TIPS Endoprosthesis
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| |
|
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| 2006M-0412
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| P030047 - Cordis PRECISE Nitinol Stent System
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| |
|
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| 2006M-0455
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| P020012 - ArteFill
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| |
|
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| 2006M-0456
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| P050022 - syngo Lung CAD
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| |
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| 2006M-0457
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| P040050 - Macroplastique Implants
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| |
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| 2006M-0459
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| P050025 - Endotex Nexstent Carotid Stent and Delivery System and Endotex Carotid Stent and Monorail Delivery System
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| |
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| 2006M-0460
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| P970053/S009 - Nidek EC-5000 Excimer Laser System
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| |
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| 2006M-0473
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| Paragon Vision Sciences, Premarket Approval for Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses for Contact Lens Corneal Refractive Therapy, P050031
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| |
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| 2006M-0490
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| P020056 - Inamed Silicone-Filled Breast Implants (Styles 10, 15, 20, 40, 45, 110, 115, and 120)
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| |
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| 2006M-0492
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| P030053 - Mentor MemoryGel Silicone Gel-Filled Breast Implants (Moderate Profile Style 7000, High Profile Style 4000, and Moderate Plus Profile Style 8000)
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| |
|
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| 2006M-0512
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| P040023 - Duraloc Option Ceramic Hip System
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| |
|
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| 2006M-0529
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| P060010 - The Spanner Temporary Prostatic Stent
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| |
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| 2006M-0530
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| P040025 - Olympic Cool-Cap
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| |
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| 2006M-0531
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| P050033 - Cosmetic Tissue Augmentation Product
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| |
|
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| 2006N-0528
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
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| |
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| 2006P-0126
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| Take specific actions with regard to the animal product that is manufactured by S&M NuTec LLC known as a "Greenie".
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| |
|
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| 2006P-0334
|
| Reclassification Petition fo Bone Heterografts
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| |
|
|
| 2006P-0402
|
| FDA would not regulate as Medical Device Assays Developed by Clinical Laboratories strictly for in-house use (home brew)
|
| |
|
|
| 2006P-0404
|
| Determine Whether Cefotan (Cefotetan Injection) has been Voluntarily Withdrawon from the Sale for Safety and Efficacy Reasons
|
| |
|
|
| 2006P-0405
|
| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
|
| |
|
|
| 2006P-0406
|
| Take appropriate remedial action against the apparent misbranding of generic azithromycin for oral suspension marketed by Pliva, Inc.
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| |
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|
| 2006P-0410
|
| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
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| |
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| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
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| | | | | | | | |
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| |
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| 2006P-0438
|
| ANDA for Betamethasone Valerate Foam (non-aerosol), 0.12%
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| |
|
|
| 2006P-0535
|
| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
|
| |
|
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| 2007N-0114
|
| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
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| |
|
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| 2007P-0044
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| Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
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| |
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| 2007P-0129
|
| To revoke the food processing permit granted to Bella Cucina Artful Food
|
| |
|
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| 2007V-0081
|
| Laser Light Show
|
| |
|
|
| 2007V-0082
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| Laser Light Show
|
| |
|
|
| 2007V-0128
|
| Laser Light Show
|
|
| |
|
| 1976N-0052G
|
| OTC general comments & combinations
|
| |
|
|
| C 235
|
| Fincastle Family Medicine
|
| Vol #:
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| 35
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
| |
|
|
| LET 19783
|
| Bluebonnet Nutrition Corporation
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19784
|
| Isomer Nutrition LLC
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19785
|
| Isomer Nutrition LLC
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19786
|
| Isomer Nutrition LLC
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19787
|
| Source Naturals
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19788
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19789
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
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| |
|
|
| LET 19790
|
| Enzymatic Therapy, Inc.
|
| Vol #:
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| 174
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| |
|
|
| LET 19791
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19792
|
| Enzymatic Therapy, Inc.
|
| Vol #:
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| 174
|
| |
|
|
| LET 19793
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19794
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19795
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19796
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19797
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19798
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19799
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19800
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19801
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19802
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19803
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19804
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19805
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19806
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
|
| | | | | | | | |
|
| |
|
| LET 19807
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19808
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19809
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19810
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19811
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19812
|
| Shining Mountain Herbs
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19813
|
| Pro-Caps Laboratories
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19814
|
| Bio-Botanica Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19815
|
| Bio-Botanica Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19816
|
| Bio-Botanica Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19817
|
| Bio-Botanica Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| LET 19818
|
| Bio-Botanica Inc.
|
| Vol #:
|
| 174
|
| |
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
| |
|
|
| C 533
|
| Form Letter Count 34
|
| Vol #:
|
| 47
|
| |
|
|
| C 534
|
| Form Letter Count 53
|
| Vol #:
|
| 48
|
| |
|
|
| C 535
|
| Form Letter Count 130
|
| Vol #:
|
| 49
|
| |
|
|
| C 536
|
| M. Park
|
| Vol #:
|
| 46
|
| |
|
|
| C 537
|
| J. Perrott
|
| Vol #:
|
| 46
|
| |
|
|
| C 538
|
| S. Gossett-Moore
|
| Vol #:
|
| 46
|
| |
|
|
| NEC 1
|
| FDA
|
| Vol #:
|
| 46
|
| |
|
|
| 2004P-0349
|
| Action on Products containing added Mercury
|
| |
|
|
| ANS 2
|
| FDA to Coalition for Mercury-Free Drugs
|
| Vol #:
|
| 4
|
| |
|
|
| 2004P-0522
|
| Off label drug use for CYTOTEC
|
| |
|
|
| SUP 4
|
| Tatia Oden French Memorial Foundation
|
| Vol #:
|
| 4
|
| |
|
|
| 2005D-0468
|
| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
|
| |
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
|
| |
|
|
| NAD 2
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005H-0271
|
| Civil Money Penalty: TMJ Implants, Inc.
|
| |
|
|
| CS 24
|
| FDA/DDM
|
| Vol #:
|
| 240
|
| |
|
|
| OR 23
|
| FDA/Administrative Law Judge
|
| Vol #:
|
| 240
|
|
| |
|
| 2005N-0262
|
| Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program
|
| |
|
|
| LET 16
|
| Eli Lilly and Company
|
| Vol #:
|
| 2
|
| |
|
|
| 2005N-0279
|
| Food Labeling; Gluten-Free Labeling of Foods
|
|
| | | | | | | | |
|
| |
|
| C 702
|
| L. Westbrook
|
| Vol #:
|
| 32
|
| |
|
|
| C 703
|
| P. K. Sharp
|
| Vol #:
|
| 32
|
| |
|
|
| C 704
|
| C. R. Hawkins
|
| Vol #:
|
| 32
|
| |
|
|
| C 705
|
| R. Wheeler
|
| Vol #:
|
| 32
|
| |
|
|
| C 706
|
| J. T. Mills
|
| Vol #:
|
| 32
|
| |
|
|
| C 707
|
| L. Jannehill
|
| Vol #:
|
| 32
|
| |
|
|
| C 708
|
| G. W. Fletcher
|
| Vol #:
|
| 32
|
| |
|
|
| C 709
|
| V. Jamroz
|
| Vol #:
|
| 32
|
| |
|
|
| C 710
|
| C. McGillen
|
| Vol #:
|
| 32
|
| |
|
|
| C 711
|
| S. Flanders
|
| Vol #:
|
| 32
|
| |
|
|
| C 712
|
| Mrs. A.K. Braswell
|
| Vol #:
|
| 32
|
| |
|
|
| C 713
|
| H. M. Cline
|
| Vol #:
|
| 32
|
| |
|
|
| C 714
|
| J. J. Coppola
|
| Vol #:
|
| 32
|
| |
|
|
| EC 1867
|
| Ms. Kelly Ladesic
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1868
|
| Mrs. Heidi Kime
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1869
|
| Mrs. Susan Roenke
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1870
|
| Mrs. KATHLEEN MILLER
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1871
|
| Mrs. Lynn Kolonauski
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1872
|
| Mrs. Rosemarie Nestasia
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1873
|
| Mrs. Heather Kenyon
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1874
|
| Ms. Deborah Parise
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1875
|
| Mrs. Katharine Johnson
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1876
|
| none
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1877
|
| Mrs. Janet Erb
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1878
|
| Ms. Mary Peters
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1879
|
| Mrs. monica melinson
|
| Vol #:
|
| 31
|
| |
|
|
| EC 1880
|
| Ms. Brian Gabel
|
| Vol #:
|
| 31
|
| |
|
|
| LET 1
|
| Oklahoma Celiac Support Group
|
| Vol #:
|
| 32
|
| |
|
|
| 2005N-0373
|
| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
|
| |
|
|
| C 13
|
| Hoffmann-La Roche Inc
|
| Vol #:
|
| 9
|
| |
|
|
| C 14
|
| South American Gelatine Manufacturers's Association
|
| Vol #:
|
| 9
|
| |
|
|
| 2005N-0471
|
| Immunology and Microbiology Devices: Reclassification of Herpes Simplex Virus (Types 1 and/or 2) Serological Assays
|
| |
|
|
| NFR 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0347
|
| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
|
| |
|
|
| EC 70
|
| Personalized Medicine Coalition
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
| |
|
| EC 71
|
| Advanced Medical Technology Association
|
| Vol #:
|
| 2
|
| |
|
|
| EC 72
|
| Johns Hopkins Genetics and Public Policy Center
|
| Vol #:
|
| 2
|
| |
|
|
| EC 73
|
| National Breast Cancer Coalition Fund
|
| Vol #:
|
| 2
|
| |
|
|
| EC 74
|
| Research Advocacy Network
|
| Vol #:
|
| 2
|
| |
|
|
| EC 75
|
| AviaraDx
|
| Vol #:
|
| 2
|
| |
|
|
| EC 76
|
| Marti Nelson Cancer Foundation
|
| Vol #:
|
| 2
|
| |
|
|
| EC 77
|
| Association for Molecular Pathology (AMP)
|
| Vol #:
|
| 2
|
| |
|
|
| EC 78
|
| Advanced Medical Technology Association
|
| Vol #:
|
| 2
|
| |
|
|
| EC 79
|
| Coalition for 21st Century Medicine
|
| Vol #:
|
| 2
|
| |
|
|
| EC 80
|
| Mohr Davidow Ventures
|
| Vol #:
|
| 2
|
| |
|
|
| EC 81
|
| Genentech, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 82
|
| Ventana Medical Systems, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 83
|
| Genentech, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 84
|
| American Society for Clinical Laboratory Science
|
| Vol #:
|
| 2
|
| |
|
|
| EC 85
|
| Mohr Davidow Ventures
|
| Vol #:
|
| 2
|
| |
|
|
| 2006D-0504
|
| Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices
|
| |
|
|
| C 6
|
| RTCA Inc
|
| Vol #:
|
| 1
|
| |
|
|
| C 7
|
| Haemonetics Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| EC 7
|
| Hospira Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 8
|
| Wi-Fi Alliance
|
| Vol #:
|
| 1
|
| |
|
|
| EC 9
|
| IEEE 802.18 Radio Regulatory TAG
|
| Vol #:
|
| 1
|
| |
|
|
| EC 10
|
| LifeScan, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 11
|
| Draeger Medical
|
| Vol #:
|
| 1
|
| |
|
|
| EC 12
|
| BIOTRONIK, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 13
|
| Kaiser Permanente
|
| Vol #:
|
| 1
|
| |
|
|
| EC 14
|
| Massachusetts Health Data Consortium, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2006M-0396
|
| P050038 - Arista AH Absorbable Hemostat
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| |
|
| 2006M-0411
|
| P040027 - GORE VIATORR TIPS Endoprosthesis
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006M-0412
|
| P030047 - Cordis PRECISE Nitinol Stent System
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006M-0455
|
| P020012 - ArteFill
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2006M-0456
|
| P050022 - syngo Lung CAD
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006M-0457
|
| P040050 - Macroplastique Implants
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
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| |
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| 2006M-0459
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| P050025 - Endotex Nexstent Carotid Stent and Delivery System and Endotex Carotid Stent and Monorail Delivery System
|
| |
|
|
| NAL 1
|
| FDA
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| Vol #:
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| 1
|
| |
|
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| 2006M-0460
|
| P970053/S009 - Nidek EC-5000 Excimer Laser System
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| |
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| NAL 1
|
| FDA
|
| Vol #:
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| 1
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| |
|
|
| 2006M-0473
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| Paragon Vision Sciences, Premarket Approval for Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses for Contact Lens Corneal Refractive Therapy, P050031
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| |
|
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| NAL 1
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| FDA
|
| Vol #:
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| 1
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| |
|
|
| 2006M-0490
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| P020056 - Inamed Silicone-Filled Breast Implants (Styles 10, 15, 20, 40, 45, 110, 115, and 120)
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| |
|
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| NAL 1
|
| FDA
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| Vol #:
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| 1
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| |
|
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| 2006M-0492
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| P030053 - Mentor MemoryGel Silicone Gel-Filled Breast Implants (Moderate Profile Style 7000, High Profile Style 4000, and Moderate Plus Profile Style 8000)
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| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2006M-0512
|
| P040023 - Duraloc Option Ceramic Hip System
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| |
|
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| NAL 1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2006M-0529
|
| P060010 - The Spanner Temporary Prostatic Stent
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| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
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| 1
|
|
| |
|
| 2006M-0530
|
| P040025 - Olympic Cool-Cap
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2006M-0531
|
| P050033 - Cosmetic Tissue Augmentation Product
|
| |
|
|
| NAL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0528
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
|
| |
|
|
| EC 1
|
| International Formula Council
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0126
|
| Take specific actions with regard to the animal product that is manufactured by S&M NuTec LLC known as a "Greenie".
|
| |
|
|
| LET 2
|
| FDA/CVM to R Wyde etc.
|
| Vol #:
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| 2
|
| |
|
|
| 2006P-0334
|
| Reclassification Petition fo Bone Heterografts
|
| |
|
|
| C 2
|
| Regeneration Technologies Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0402
|
| FDA would not regulate as Medical Device Assays Developed by Clinical Laboratories strictly for in-house use (home brew)
|
|
| | | | | | | | |
|
| |
|
| EC 3
|
| Life Sciences Management Group, Inc.
|
| Vol #:
|
| 2
|
| |
|
|
| EC 4
|
| National Tay-Sachs
|
| Vol #:
|
| 2
|
|
| |
|
| 2006P-0404
|
| Determine Whether Cefotan (Cefotetan Injection) has been Voluntarily Withdrawon from the Sale for Safety and Efficacy Reasons
|
| |
|
|
| LET 1
|
| FDA/CDER to B Braun Medical Inc
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0405
|
| Require full prescribing information of all antiepileptic drugs contain specific language under Warnings or Warnings and Precautions
|
| |
|
|
| C 1
|
| Georgia House of Representatives
|
| Vol #:
|
| 2
|
| |
|
|
| EC 1
|
| Kentucky General Assembly
|
| Vol #:
|
| 2
|
| |
|
|
| EC 2
|
| Mrs. Margo Knight
|
| Vol #:
|
| 2
|
| |
|
|
| EC 3
|
| Ms. Elizabeth Cooksey
|
| Vol #:
|
| 2
|
| |
|
|
| EC 4
|
| Mrs. Michele Gasaway
|
| Vol #:
|
| 2
|
| |
|
|
| EC 5
|
| Ms. Audrey Autrey
|
| Vol #:
|
| 2
|
| |
|
|
| EC 6
|
| Mr. Bill Draper
|
| Vol #:
|
| 2
|
| |
|
|
| EC 7
|
| Children's Epilepsy Center
|
| Vol #:
|
| 2
|
| |
|
|
| EC 8
|
| Miss. Ashley Baldwin
|
| Vol #:
|
| 2
|
| |
|
|
| EC 9
|
| Mrs. Robin Cox
|
| Vol #:
|
| 2
|
| |
|
|
| EC 10
|
| Ms. Caroline Morais
|
| Vol #:
|
| 2
|
| |
|
|
| EC 11
|
| Mrs. Sheila Blanton
|
| Vol #:
|
| 2
|
| |
|
|
| 2006P-0406
|
| Take appropriate remedial action against the apparent misbranding of generic azithromycin for oral suspension marketed by Pliva, Inc.
|
| |
|
|
| LET 1
|
| FDA/CDER to Pfizer Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0410
|
| Refuse to approve any ANDA for amifostine product with labeling which omits dosage and other information
|
| |
|
|
| C 5
|
| Sun Pharmaceutical Industries Ltd
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
| | |
|
|
| C 55
|
| R Baer
|
| Vol #:
|
| 6
|
| |
|
|
| C 56
|
| D Napoli
|
| Vol #:
|
| 6
|
| |
|
|
| C 57
|
| D Greer
|
| Vol #:
|
| 6
|
| |
|
|
| 2006P-0438
|
| ANDA for Betamethasone Valerate Foam (non-aerosol), 0.12%
|
| |
|
|
| RC 1
|
| Connectics Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0535
|
| Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
|
| |
|
|
| ANS 1
|
| FDA to Coalition for Mercury-Free Drugs
|
| Vol #:
|
| 2
|
| |
|
|
| 2007N-0114
|
| Electronic Distribution of Prescribing Information for Prescription Drug Products; Public Hearing
|
| |
|
|
| EAPE 1
|
| Garber, Mat
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 2
|
| Menchaca, Ramon
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| EAPE 3
|
| Todes, Jack
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 4
|
| Jaeger, Arthur
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 5
|
| Ballinger, Regina
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 6
|
| Mayhew, Brian
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 7
|
| Foster, Bill
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 8
|
| Fraij, Tony
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 9
|
| Mybeck, Kathy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 10
|
| Mybeck, Kathy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 11
|
| Hetrick, Lauren
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 12
|
| McNeil, Melodi
|
| Vol #:
|
| 1
|
|
| |
|
| 2007P-0044
|
| Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
|
| |
|
|
| SUP 1
|
| Public Citizen
|
| Vol #:
|
| 5
|
| |
|
|
| 2007P-0129
|
| To revoke the food processing permit granted to Bella Cucina Artful Food
|
| |
|
|
| ACK 1
|
| FDA/DDM to C Smith
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| C Smith
|
| Vol #:
|
| 1
|
| |
|
|
| 2007V-0081
|
| Laser Light Show
|
| |
|
|
| VRA 1
|
| FDA/CDRH to Fusion Laser Light Show
|
| Vol #:
|
| 1
|
| |
|
|
| 2007V-0082
|
| Laser Light Show
|
| |
|
|
| VRA 1
|
| FDA/CDRH to Information Database Solutions
|
| Vol #:
|
| 1
|
| |
|
|
| 2007V-0128
|
| Laser Light Show
|
| |
|
|
| ACK 1
|
| FDA/ DDM to Sunset Productions
|
| Vol #:
|
| 1
|
| |
|
|
| VAR 1
|
| Sunset Productions
|
| Vol #:
|
| 1
|
|
|
