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| Dockets Entered
On April 25, 2007
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| Docket #
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| Title
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| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| 2000N-1596
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| Uniform Compliance Date for Food Labeling Regulations
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| 2001D-0221
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| Biological Product Deviation Reporting for Licensed Manufact
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| 2001D-0432
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| Evalution of the effects of Orally Inhaled and Intranasal
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003D-0044
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| Reporting Results for Studies Evaluating Diagnostic Tests
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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-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004D-0228
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| Guidance for Industry on Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV'
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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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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| 2005N-0272
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| Irradiation in the Production, Processing, and Handling of Food
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| 2005N-0279
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| Food Labeling; Gluten-Free Labeling of Foods
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| 2006D-0275
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems
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| 2006D-0480
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| Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration
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| 2006N-0475
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
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| 2006P-0371
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| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market 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-0442
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via
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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-0118
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| Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
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| 2007N-0014
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and GRAS Affirmation; Electronic Submission
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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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| 2007P-0044
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| Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis
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| 2007P-0147
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| Use of the Term Natural Consistent with USDA's Food Safety and Inspection Service
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| 1998N-0337C
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| Definition and Option of Alternative Labeling Requirements for Convenience-Size OTC Drug Packages
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| EC 3
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| Wyeth Consumer Healthcare
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| Vol #:
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| 1
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| EC 4
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| Wyeth Consumer Health Care
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| Vol #:
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| 1
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| 2000N-1596
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| Uniform Compliance Date for Food Labeling Regulations
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| EC 3
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| Ms. Janet Beazley
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| Vol #:
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| 1
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| EC 4
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| Ms. Ruby Hayes
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| Vol #:
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| 1
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| 2001D-0221
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| Biological Product Deviation Reporting for Licensed Manufact
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| EC 2
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| Mr. richard simnitt
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| Vol #:
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| 1
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| 2001D-0432
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| Evalution of the effects of Orally Inhaled and Intranasal
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| EC 1
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| Ms. Pam Kanazawich
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| Vol #:
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| 1
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 797
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| J. Bowen
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| Vol #:
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| 10
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| EMC 798
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| Calorie Control Council
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| Vol #:
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| 10
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| EMC 799
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| Mission Possible International
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| Vol #:
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| 10
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| EMC 800
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| Mission Possible International
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| Vol #:
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| 10
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| 2003D-0044
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| Reporting Results for Studies Evaluating Diagnostic Tests
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| EC 4
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| Dr. Timothy Leary
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| Vol #:
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| 1
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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 1475
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| L. Coxon
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| Vol #:
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| 12
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| EMC 1476
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| B. Lanier
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| Vol #:
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| 12
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| EMC 1477
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| S. Henderson
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| Vol #:
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| 12
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| EMC 1478
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| Oficial de Prensa, DACO
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| Vol #:
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| 12
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| EMC 1479
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| L. Keany
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| Vol #:
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| 12
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC 97
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| DREAMWEAVERS LLC
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| Vol #:
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| 8
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| EC 5961
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| Mrs. debra paulsen
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| Vol #:
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| 60
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| EC 5962
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| Ignorance is bliss for the governments people
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| Vol #:
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| 60
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| EC 5963
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| Ms. Anita Ward
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| Vol #:
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| 60
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| EC 5964
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| Mrs. Amy Cattafi
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| Vol #:
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| 60
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| EC 5965
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| Ms. Dianne Douglas
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| Vol #:
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| 60
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| EC 5966
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| Ms. Dianne Douglas
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| Vol #:
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| 60
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| EC 5967
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| Mr. Joseph Bender
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| Vol #:
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| 60
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| EC 5968
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| Ms. Cheryl Jones
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| Vol #:
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| 60
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| EC 5969
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| Amvets Post 67
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| Vol #:
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| 60
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| EC 5970
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| Ms. Mare Florentino
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| Vol #:
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| 60
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| EC 5971
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| Mr. Haider Khattak
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| Vol #:
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| 60
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| EC 5972
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| Miss. Kate Cushen
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| Vol #:
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| 60
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| EC 5973
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| Ms. Alexandra Sola
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| Vol #:
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| 60
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| EC 5974
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| Mrs. Laura Brill
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| Vol #:
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| 60
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| EMC 170
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| J. Carr
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| Vol #:
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| 7
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| EMC 171
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| D. Citarella
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| Vol #:
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| 7
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| EMC 172
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| F. Karnes
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| Vol #:
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| 7
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| EMC 173
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| M. Reinbold
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| Vol #:
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| 7
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| EMC 174
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| P. Haring
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| Vol #:
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| 7
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| EMC 175
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| M. Weeks
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| Vol #:
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| 7
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| 2006N-0475
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
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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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| 2006P-0371
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| Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
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| EC 13
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| Mrs. Susan Flippo
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| Vol #:
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| 1
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| EC 1084
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| Mrs. Susa mITCHELL
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| Vol #:
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| 8
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| EC 1085
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| Mr. Jeff Newport
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| Vol #:
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| 8
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| EC 1086
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| n/a
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| Vol #:
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| 8
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| EC 1087
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| Ms. Vahn Wagner
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| Vol #:
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| 8
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| EC 1088
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| Ms. Sharon Ouimet
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| Vol #:
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| 8
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| EC 1089
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| Ms. amy pickering
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| Vol #:
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| 8
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| 2006P-0442
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| Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via
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| EC 1
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| Mrs. Sonia Schulman
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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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| EC 1
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| STATKING Consulting, Inc.
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| Vol #:
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| 1
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| 2007D-0118
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| Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
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| EC 1
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| ORIDDC
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| Vol #:
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| 1
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| 2007N-0014
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and GRAS Affirmation; Electronic Submission
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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-0121
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| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
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| EAPE 107
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| Johnston, Gordon
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| Vol #:
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| 1
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| EAPE 108
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| Miller, Catherine
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| Vol #:
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| 1
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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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