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| Dockets Entered
On January 24, 2007
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| Docket #
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| Title
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| 1978N-0065
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| Skin Bleaching Drug Products
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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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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| 2006D-0353
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| Guidance for Industry and FDA Staff: Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006D-0400
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| Global Harmonization Task Force, Study Groups 1, 2, 4, and 5; New Proposed and Final Documents; Availability
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| 2006D-0408
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| Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications
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| 2006D-0413
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| Guidance for Industry: Blue Bird Medicated Feed Labels
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| 2006N-0036
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 2006P-0511
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| Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822
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| 2007E-0035
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| Patent Extension Application for Vusion Ointment, U.S. Patent No. 4,911,932
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| 2007M-0032
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| P050018 - AngioSculpt Scoring Balloon Catheter
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| 2007P-0034
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| To make a determination on three (3) reference listed drug products that have not been withdrawn from commercial distribution for reasons other than safety or effectiveness
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| 1978N-0065
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| Skin Bleaching Drug Products
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| EMC 5
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| SkinMedica Cosmeceuticals
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| Vol #:
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| 20
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4437
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| S. Hall
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| Vol #:
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| 320
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 755
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| M. Stangle
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| Vol #:
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| 10
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1429
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| United Way of Washington County, Arkansas
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| Vol #:
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| 12
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| |
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| EMC 56
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| No Submitter
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| Vol #:
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| 5
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| |
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| EMC 57
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| R. Martin
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| Vol #:
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| 5
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| |
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| EMC 58
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| A. Ruiz
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| Vol #:
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| 5
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| EMC 59
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| M. Johnson
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| Vol #:
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| 5
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| |
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| EMC 60
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| E. Henry
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| Vol #:
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| 5
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|
| | | | | | | | |
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| EMC 61
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| L. John
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| Vol #:
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| 5
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| |
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| EMC 62
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| S. & D. Hesse
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| Vol #:
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| 5
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| |
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| EMC 63
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| P. Lalouken
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| Vol #:
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| 5
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| |
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| EMC 64
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| A. Pavelich
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| Vol #:
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| 5
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| |
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| EMC 65
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| A. Rami
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| Vol #:
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| 5
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| |
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| EMC 66
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| A. Berkson
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| Vol #:
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| 5
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| |
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| EMC 67
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| A. Judd
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| Vol #:
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| 5
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| |
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| EMC 68
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| A. Rosen
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| Vol #:
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| 5
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| |
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| EMC 69
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| B. Tokar
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| Vol #:
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| 5
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| |
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| EMC 70
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| B. Sutter
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| Vol #:
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| 5
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| |
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| EMC 71
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| M. Berk
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| Vol #:
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| 5
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| EMC 72
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| D. Wichar
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| Vol #:
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| 5
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| |
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| EMC 73
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| S. Sanders
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| Vol #:
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| 5
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| |
|
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| EMC 74
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| G. & B. Freeman
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| Vol #:
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| 5
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| |
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| EMC 75
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| M. Grappo
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| Vol #:
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| 5
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| |
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| EMC 76
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| K. O'Neil
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| Vol #:
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| 5
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| |
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| EMC 77
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| M. Dunne
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| Vol #:
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| 5
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| |
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| EMC 78
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| B. DeLancey
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| Vol #:
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| 5
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| |
|
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| EMC 79
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| K. Simon
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| Vol #:
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| 5
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| |
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| EMC 80
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| M. Hayman
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| Vol #:
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| 5
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| |
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| EMC 81
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| T. Biediger
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| Vol #:
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| 5
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| |
|
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| EMC 82
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| L. Frank
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| Vol #:
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| 5
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| |
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| EMC 83
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| S. Haley
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| Vol #:
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| 5
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| EMC 84
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| J. Webb
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| Vol #:
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| 5
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| |
|
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| 2005N-0403
|
| 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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| C 29
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| Pharmion Coporation
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| Vol #:
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| 3
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| |
|
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| 2006D-0353
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| Guidance for Industry and FDA Staff: Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
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| |
|
|
| C 1
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| Abbott Laboratories
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| Vol #:
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| 1
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| |
|
|
| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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|
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|
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| C 1248
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| T and A rave
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| Vol #:
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| 42
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| |
|
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| C 1249
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| J. Allen
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| Vol #:
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| 42
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| |
|
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| C 1250
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| Mr and Mrs R Andrews
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| Vol #:
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| 42
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| |
|
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| C 1251
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| R. Cacka
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| Vol #:
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| 42
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|
| | | | | | | |
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| |
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| C 1252
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| A. Collins
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| Vol #:
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| 42
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| |
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| C 1253
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| J. Wieber
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| Vol #:
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| 42
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| |
|
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| C 1254
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| Dr and M M. Spakovsky
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| Vol #:
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| 42
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| |
|
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| C 1255
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| J. House
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| Vol #:
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| 42
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| |
|
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| C 1256
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| C. Niedos
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| Vol #:
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| 42
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| |
|
|
| C 1257
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| M. Harold
|
| Vol #:
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| 42
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| |
|
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| C 1258
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| A. Synovic
|
| Vol #:
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| 42
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| |
|
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| C 1259
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| M. Osborne
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| Vol #:
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| 42
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| |
|
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| C 1260
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| A. Thomas
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| Vol #:
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| 42
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| |
|
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| C 1261
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| F. Stout
|
| Vol #:
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| 42
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| |
|
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| C 1262
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| M. Pauwels
|
| Vol #:
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| 42
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| |
|
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| C 1263
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| M. Hutchinson
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| Vol #:
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| 42
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| |
|
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| C 1264
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| C. Leon
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| Vol #:
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| 42
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| |
|
|
| C 1265
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| H. Vagley
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| Vol #:
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| 42
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| |
|
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| C 1266
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| E. Rome
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| Vol #:
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| 42
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| |
|
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| C 1267
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| M. Brunyansky
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| Vol #:
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| 42
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| |
|
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| C 1268
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| Association for World Peace, Justice and the Messianic-Charismatic Development of Peoples
|
| Vol #:
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| 42
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| |
|
|
| C 1269
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| J. Capozzelli
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| Vol #:
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| 42
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| |
|
|
| C 1270
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| A. Nakamura et al.
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| Vol #:
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| 42
|
| |
|
|
| C 1271
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| L. Jennings
|
| Vol #:
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| 42
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| |
|
|
| C 1272
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| L. LeBlanc
|
| Vol #:
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| 42
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| |
|
|
| C 1273
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| J. Janhawski
|
| Vol #:
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| 42
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| |
|
|
| C 1274
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| F. Jackson
|
| Vol #:
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| 42
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| |
|
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| C 1275
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| R and M Lindenfelser
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| Vol #:
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| 42
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| |
|
|
| C 1276
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| C. Wright
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| Vol #:
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| 42
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| |
|
|
| C 1277
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| M. Wright
|
| Vol #:
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| 42
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| |
|
|
| C 1278
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| C. Niedos
|
| Vol #:
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| 42
|
| |
|
|
| C 1279
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| M and L Detera
|
| Vol #:
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| 42
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| |
|
|
| C 1280
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| K. Miller
|
| Vol #:
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| 42
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| |
|
|
| C 1281
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| J. Karlovitz
|
| Vol #:
|
| 42
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| |
|
|
| C 1282
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| V. Walter
|
| Vol #:
|
| 42
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| |
|
|
| C 1283
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| A. Ferraro
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| Vol #:
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| 42
|
| |
|
|
| C 1284
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| L. Harris
|
| Vol #:
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| 42
|
| |
|
|
| C 1285
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| M. Kirchner
|
| Vol #:
|
| 42
|
| |
|
|
| C 1286
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| P. Griffith
|
| Vol #:
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| 42
|
| |
|
|
| C 1287
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| J. DiMaggio, III
|
| Vol #:
|
| 42
|
| |
|
|
| C 1288
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| M. Vicente
|
| Vol #:
|
| 42
|
|
| | | | | | | |
|
| |
|
| C 1289
|
| B and J Bauer
|
| Vol #:
|
| 42
|
| |
|
|
| C 1290
|
| D. Nugent
|
| Vol #:
|
| 42
|
| |
|
|
| C 1291
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| G and P Smith
|
| Vol #:
|
| 42
|
| |
|
|
| C 1292
|
| F. Wheeler
|
| Vol #:
|
| 42
|
| |
|
|
| C 1293
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| R and K Meidl
|
| Vol #:
|
| 42
|
| |
|
|
| C 1294
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| W. Grossklas
|
| Vol #:
|
| 42
|
| |
|
|
| C 1295
|
| F. Smith, M.D.
|
| Vol #:
|
| 42
|
| |
|
|
| C 1296
|
| M. Griffith
|
| Vol #:
|
| 42
|
| |
|
|
| C 1297
|
| R. Lewis
|
| Vol #:
|
| 42
|
| |
|
|
| C 1298
|
| F and J Amy
|
| Vol #:
|
| 42
|
| |
|
|
| C 1299
|
| M. Levings
|
| Vol #:
|
| 42
|
| |
|
|
| C 1300
|
| S. Warrick
|
| Vol #:
|
| 42
|
| |
|
|
| C 1301
|
| J. Pindell
|
| Vol #:
|
| 42
|
| |
|
|
| C 1302
|
| R and L Feldpausch
|
| Vol #:
|
| 42
|
| |
|
|
| C 1303
|
| B and M Kaiser
|
| Vol #:
|
| 42
|
| |
|
|
| C 1304
|
| P and A Schafer
|
| Vol #:
|
| 42
|
| |
|
|
| C 1305
|
| A. Petullo
|
| Vol #:
|
| 42
|
| |
|
|
| C 1306
|
| K. Franklin
|
| Vol #:
|
| 42
|
| |
|
|
| C 1307
|
| M. Wiedemer
|
| Vol #:
|
| 42
|
| |
|
|
| C 1308
|
| Decatur Gastroenterology Associates, P.C.
|
| Vol #:
|
| 42
|
| |
|
|
| C 1309
|
| M. Ridge
|
| Vol #:
|
| 42
|
| |
|
|
| C 1310
|
| D. Watt
|
| Vol #:
|
| 42
|
| |
|
|
| C 1311
|
| F. Alessio
|
| Vol #:
|
| 44
|
| |
|
|
| C 1312
|
| L. Webb
|
| Vol #:
|
| 44
|
| |
|
|
| C 1313
|
| L. Martinez
|
| Vol #:
|
| 44
|
| |
|
|
| C 1314
|
| J. Factor
|
| Vol #:
|
| 44
|
| |
|
|
| C 1315
|
| V. Danforth
|
| Vol #:
|
| 44
|
| |
|
|
| C 1316
|
| R. Danforth
|
| Vol #:
|
| 44
|
| |
|
|
| C 1317
|
| H. Ruffalo
|
| Vol #:
|
| 44
|
| |
|
|
| C 1318
|
| M. Harrison
|
| Vol #:
|
| 44
|
| |
|
|
| C 1319
|
| K. Surmont
|
| Vol #:
|
| 44
|
| |
|
|
| C 1320
|
| J. Page
|
| Vol #:
|
| 44
|
| |
|
|
| C 1321
|
| J. Donnelly
|
| Vol #:
|
| 44
|
| |
|
|
| C 1322
|
| D. Detty
|
| Vol #:
|
| 44
|
| |
|
|
| C 1323
|
| M. Niedospial
|
| Vol #:
|
| 44
|
| |
|
|
| C 1324
|
| P. Menconi
|
| Vol #:
|
| 44
|
| |
|
|
| C 1325
|
| R. Kohl
|
| Vol #:
|
| 44
|
|
| | | | | | | |
|
| |
|
| C 1326
|
| B and C McCarthy
|
| Vol #:
|
| 44
|
| |
|
|
| C 1327
|
| E. Leaf
|
| Vol #:
|
| 44
|
| |
|
|
| C 1328
|
| A. Trew
|
| Vol #:
|
| 44
|
| |
|
|
| C 1329
|
| R. Trew
|
| Vol #:
|
| 44
|
| |
|
|
| C 1330
|
| K. Maggio, MD
|
| Vol #:
|
| 44
|
| |
|
|
| C 1331
|
| E. McGuirk
|
| Vol #:
|
| 44
|
| |
|
|
| C 1332
|
| M. McGuirk
|
| Vol #:
|
| 44
|
| |
|
|
| C 1333
|
| C. McGuirk
|
| Vol #:
|
| 44
|
| |
|
|
| C 1334
|
| A. Swinson
|
| Vol #:
|
| 44
|
| |
|
|
| C 1335
|
| E. Gaven
|
| Vol #:
|
| 44
|
| |
|
|
| C 1336
|
| K. Simon
|
| Vol #:
|
| 44
|
| |
|
|
| C 1337
|
| M. Wilson
|
| Vol #:
|
| 44
|
| |
|
|
| C 1338
|
| L. Cahill, MD
|
| Vol #:
|
| 44
|
| |
|
|
| C 1339
|
| R. Chamberlain
|
| Vol #:
|
| 44
|
| |
|
|
| C 1340
|
| A. Nugent
|
| Vol #:
|
| 44
|
| |
|
|
| C 1341
|
| L. Favreau
|
| Vol #:
|
| 44
|
| |
|
|
| C 1342
|
| D. Brekalo
|
| Vol #:
|
| 44
|
| |
|
|
| C 1343
|
| Illigible
|
| Vol #:
|
| 44
|
| |
|
|
| C 1344
|
| M. Weed
|
| Vol #:
|
| 44
|
| |
|
|
| C 1345
|
| M. Weltzer
|
| Vol #:
|
| 44
|
| |
|
|
| C 1346
|
| D. Karano
|
| Vol #:
|
| 44
|
| |
|
|
| C 1347
|
| K and C DeCeault
|
| Vol #:
|
| 44
|
| |
|
|
| C 1348
|
| R. Brink
|
| Vol #:
|
| 44
|
| |
|
|
| C 1349
|
| Dr and Mrs J. Calabro
|
| Vol #:
|
| 44
|
| |
|
|
| C 1350
|
| J. Weaver
|
| Vol #:
|
| 44
|
| |
|
|
| C 1351
|
| M. Hepler
|
| Vol #:
|
| 44
|
| |
|
|
| C 1352
|
| T. Dygert
|
| Vol #:
|
| 44
|
| |
|
|
| C 1353
|
| R. Tissot
|
| Vol #:
|
| 44
|
| |
|
|
| C 1354
|
| No siganture
|
| Vol #:
|
| 44
|
| |
|
|
| C 1355
|
| J. Hogan
|
| Vol #:
|
| 44
|
| |
|
|
| C 1356
|
| J. Gentile
|
| Vol #:
|
| 44
|
| |
|
|
| C 1357
|
| No signature
|
| Vol #:
|
| 44
|
| |
|
|
| C 1358
|
| No signature
|
| Vol #:
|
| 44
|
| |
|
|
| C 1359
|
| D. Gomolski
|
| Vol #:
|
| 44
|
| |
|
|
| C 1360
|
| L. Pillar
|
| Vol #:
|
| 44
|
| |
|
|
| C 1361
|
| S. Martensen
|
| Vol #:
|
| 44
|
| |
|
|
| C 1362
|
| J. Wilson
|
| Vol #:
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| 44
|
|
| | | | | | | | |
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| |
|
| C 1363
|
| D. Calderon
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| Vol #:
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| 44
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| |
|
|
| C 1364
|
| H. Walter
|
| Vol #:
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| 44
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| |
|
|
| C 1365
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| D. Opferman
|
| Vol #:
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| 44
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| |
|
|
| C 1366
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| P. Messina
|
| Vol #:
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| 44
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| |
|
|
| C 1367
|
| A and R Mglatt
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| Vol #:
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| 44
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| |
|
|
| C 1368
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| T. Huether
|
| Vol #:
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| 44
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| |
|
|
| C 1369
|
| E. Roling et al.
|
| Vol #:
|
| 44
|
| |
|
|
| C 1370
|
| M. Menez
|
| Vol #:
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| 44
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| |
|
|
| C 1371
|
| B and C Glaser
|
| Vol #:
|
| 44
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| |
|
|
| C 1372
|
| P. Hoffman
|
| Vol #:
|
| 44
|
| |
|
|
| C 1373
|
| A. Nugent
|
| Vol #:
|
| 44
|
| |
|
|
| C 1374
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| P. Kraemer
|
| Vol #:
|
| 44
|
| |
|
|
| C 1375
|
| V. DeSomber, RN
|
| Vol #:
|
| 44
|
| |
|
|
| C 1376
|
| K. Tuncy
|
| Vol #:
|
| 44
|
| |
|
|
| C 1377
|
| D. Hoffman
|
| Vol #:
|
| 44
|
| |
|
|
| C 1378
|
| A. Nugent
|
| Vol #:
|
| 44
|
| |
|
|
| C 1379
|
| P. Moran
|
| Vol #:
|
| 44
|
| |
|
|
| C 1380
|
| J. Glendening
|
| Vol #:
|
| 44
|
| |
|
|
| C 1381
|
| C. Sowa
|
| Vol #:
|
| 44
|
| |
|
|
| C 1382
|
| A. Reardon
|
| Vol #:
|
| 44
|
| |
|
|
| C 1383
|
| J. Kirchner
|
| Vol #:
|
| 44
|
| |
|
|
| C 1384
|
| G. Hoffner
|
| Vol #:
|
| 44
|
| |
|
|
| C 1385
|
| P. Geczy
|
| Vol #:
|
| 44
|
| |
|
|
| C 1386
|
| J and D Giallombardo
|
| Vol #:
|
| 44
|
| |
|
|
| 2006D-0400
|
| Global Harmonization Task Force, Study Groups 1, 2, 4, and 5; New Proposed and Final Documents; Availability
|
| |
|
|
| C 1
|
| Sanofi-aventis US LLC
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0408
|
| Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications
|
| |
|
|
| C 2
|
| Ortho-Clinical Diagnostics, Inc. (OCD)
|
| Vol #:
|
| 1
|
| |
|
|
| C 3
|
| St. Jude Medical (SJM)
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0413
|
| Guidance for Industry: Blue Bird Medicated Feed Labels
|
| |
|
|
| C 1
|
| State of Washington
|
| Vol #:
|
| 1
|
| |
|
|
| 2006N-0036
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
|
|
|
|
|
|
|
|
|
|
|
| EMC 14
|
| D. Miller
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
| |
|
|
| C 27
|
| D. Luck
|
| Vol #:
|
| 6
|
| |
|
|
| C 28
|
| Rose Acre Farms
|
| Vol #:
|
| 6
|
| |
|
|
| C 29
|
| Daybreak Foods, Inc.
|
| Vol #:
|
| 6
|
| |
|
|
| C 30
|
| J.S. West Milling
|
| Vol #:
|
| 6
|
| |
|
|
| C 31
|
| K. McNulty
|
| Vol #:
|
| 6
|
| |
|
|
| C 32
|
| Tampa Famr Service, Inc.
|
| Vol #:
|
| 6
|
| |
|
|
| C 33
|
| Morning Fresh Farms
|
| Vol #:
|
| 6
|
| |
|
|
| C 34
|
| No signature
|
| Vol #:
|
| 6
|
| |
|
|
| C 35
|
| K. Welsh
|
| Vol #:
|
| 6
|
| |
|
|
| C 36
|
| S. Jotoku
|
| Vol #:
|
| 6
|
| |
|
|
| C 37
|
| S and H Wyck
|
| Vol #:
|
| 6
|
| |
|
|
| C 38
|
| Pearl Valley Eggs
|
| Vol #:
|
| 6
|
| |
|
|
| C 39
|
| K. Call
|
| Vol #:
|
| 6
|
| |
|
|
| C 40
|
| Feather Crest Farms, Inc.
|
| Vol #:
|
| 6
|
| |
|
|
| 2006P-0415
|
| Petition Seeking Regulation of Cloned Animals
|
| |
|
|
| C 45
|
| C. Kavina
|
| Vol #:
|
| 5
|
| |
|
|
| 2006P-0511
|
| Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822
|
| |
|
|
| C 1
|
| Mallinckrodt, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007E-0035
|
| Patent Extension Application for Vusion Ointment, U.S. Patent No. 4,911,932
|
| |
|
|
| APP 1
|
| Johnson & Johnson Consumer Companies, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007M-0032
|
| P050018 - AngioSculpt Scoring Balloon Catheter
|
| |
|
|
| AAV 1
|
| AngioScore, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0034
|
| To make a determination on three (3) reference listed drug products that have not been withdrawn from commercial distribution for reasons other than safety or effectiveness
|
| |
|
|
| ACK 1
|
| FDA / DDM to JRRapoza Associates, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| ACK 2
|
| Number not used
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| JRRapoza Associates, Inc.
|
| Vol #:
|
| 1
|
|
|
