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| Dockets Entered
On December 11, 2007
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| Docket #
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| Title
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2006M-0389
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| P050042 - ARCHITECT Anti-HCV Assay; ARCHITECT Anti-HCV Calibrator and ARCHITECT Anti-HCV Control
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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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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| 2007C-0474
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| DSM Nutritional Products, Inc.; Filing of Color Additive Petition
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| 2007D-0393
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| Guidance for Industry: Blood Establishment Computer System Validation in the Users Facility
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| 2007N-0236
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| Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Supporting Regulations, and Form FDA 356V
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| 2007N-0317
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| Agency Information Collection Activities; Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension
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| 2007N-0337
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Radioactive Drug Research Committees
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007N-0460
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals
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| 2007N-0461
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Communicating with Health Care Providers about the Risks and Benefits of Prescription Drug Use fo
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| 2007N-0469
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| Establishment of Fiscal Year 2008 User Fee Rates for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products
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| 2007P-0237
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| Clear new susceptibility test devices or modification of existing devices using Clinical and Laboratory Standards Institute (CLSI) interpretive breakpoints in those instances regarding susceptibility
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| 2007P-0274
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| Request that CDRH allow 510(k) clearance of devices for antimicrobial susceptibility testing of Streptococcus pneumoniae with pencillin
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| 2007P-0438
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| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
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| 2007P-0466
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| Prohibit the marketing of dietary supplements containing Pyridoxal 5'-Phosphate
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| 2007P-0475
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| Take the following action with respect to the scheduling and conduct of inspections associated with drugs manufactured or processed at domestic and foreign facilities
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| BKG 2
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| Background Material
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| Vol #:
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| 30
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| NEC 1
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| FDA
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| Vol #:
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| 28
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 4070
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| M. Gonzalez
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| Vol #:
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| 238
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| 2006M-0389
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| P050042 - ARCHITECT Anti-HCV Assay; ARCHITECT Anti-HCV Calibrator and ARCHITECT Anti-HCV Control
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| CR 2
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| C 4264
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| L. Borduci
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| Vol #:
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| 40
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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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| C 498
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| K. Ashley
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| Vol #:
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| 14
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| C 499
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| S. K. Perry
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| Vol #:
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| 14
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| C 500
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| C. Thiry
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| Vol #:
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| 14
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| C 501
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| B. Bonsigmore
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| Vol #:
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| 14
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| C 502
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| L. Mills
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| Vol #:
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| 14
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| C 503
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| V. Baxter
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| Vol #:
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| 14
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| C 504
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| C. T. Delgigant
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| Vol #:
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| 14
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| C 505
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| M. Lraly
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| Vol #:
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| 14
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| C 506
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| Unknown
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| Vol #:
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| 14
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| 2007C-0474
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| DSM Nutritional Products, Inc.; Filing of Color Additive Petition
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| NFL 1
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| FDA
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| Vol #:
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| 1
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| 2007D-0393
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| Guidance for Industry: Blood Establishment Computer System Validation in the Users Facility
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| EC 1
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| Blood Systems, Inc
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| Vol #:
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| 1
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| 2007N-0236
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| Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Supporting Regulations, and Form FDA 356V
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| N 2
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| FDA
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| Vol #:
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| 1
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| 2007N-0262
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
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| EC 12
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| Mr. Terry Franzel RN, BSN
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| Vol #:
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| 1
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| 2007N-0317
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| Agency Information Collection Activities; Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension
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| N 2
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| FDA
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| Vol #:
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| 1
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| 2007N-0337
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Radioactive Drug Research Committees
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| N 2
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| FDA
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| Vol #:
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| 1
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| EC 124
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| American Medical Association
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| Vol #:
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| 2
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| EC 125
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| Dr. Gary Steven
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| Vol #:
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| 2
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| 2007N-0460
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals
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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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| 2007N-0461
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Communicating with Health Care Providers about the Risks and Benefits of Prescription Drug Use fo
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| |
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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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| 2007N-0469
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| Establishment of Fiscal Year 2008 User Fee Rates for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products
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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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| 2007P-0237
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| Clear new susceptibility test devices or modification of existing devices using Clinical and Laboratory Standards Institute (CLSI) interpretive breakpoints in those instances regarding susceptibility
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| | | | | | | | |
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| LET 1
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| FDA/CDRH to Clinical and Laboratory Standards Institute
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| Vol #:
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| 1
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| 2007P-0274
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| Request that CDRH allow 510(k) clearance of devices for antimicrobial susceptibility testing of Streptococcus pneumoniae with pencillin
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|
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| LET 1
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| CDRH to Clinical and Laboratory Standards Institute
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| Vol #:
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| 2
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| 2007P-0438
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| Declare Angel Parfum, Angel Eau du Toilette and other Angel related fragranced products be declared misbranded and have their importation ceased until their safety can be independently verified
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| EC 18
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| Mrs. Sharon Kramer
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| Vol #:
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| 3
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| EC 19
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| Ms. Nancy Connelley
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| Vol #:
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| 3
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| 2007P-0466
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| Prohibit the marketing of dietary supplements containing Pyridoxal 5'-Phosphate
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| EC 1
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| Mr. Barry Cole
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| Vol #:
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| 2
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| 2007P-0475
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| Take the following action with respect to the scheduling and conduct of inspections associated with drugs manufactured or processed at domestic and foreign facilities
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| ACK 1
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| FDA/DDM to Alston & Bird LLP
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| Vol #:
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| 1
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| CP 1
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| Alston & Bird LLP
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| Vol #:
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| 1
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