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| Dockets Entered
On November 14, 2007 - Corrected Copy
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| Docket #
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| Title
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| 1978N-0038
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| Sunscreen Drug Products
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| 2006N-0168
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| Food Labeling: Reference Daily Intakes & Daily Reference Values
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| 2007D-0396
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| Drug-Induced Liver Injury: Premarketing Clinical Evaluation;Draft Guidance
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| 2007N-0277
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| Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
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| 2007N-0343
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| Electronic Nonclinical Study Data Submission; Notice of Pilot Project
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| 2007N-0347
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| Information Technology Strategic Planning; Public Meeting
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| 2007N-0382
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| Ramipril Capsules and 180-day generic drug exclusivity
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| 2007N-0417
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| Acarbose Tablets and 180-day exclusivity
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| 2007P-0320
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| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| 2007P-0400
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| Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
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| 1978N-0038
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| Sunscreen Drug Products
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| EC 2642
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| Mrs. joy fischer williams
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| Vol #:
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| 163
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| EC 2643
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| Miss. katie kjaer
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| Vol #:
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| 163
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| EC 2644
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| Ms. maria simpson
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| Vol #:
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| 163
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| EC 2645
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| Miss. Heather Lipari
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| Vol #:
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| 163
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| EC 2646
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| Ms. Victoria Alford
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| Vol #:
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| 163
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| EC 2647
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| Mr. Eric Longley
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| Vol #:
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| 163
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| EC 2648
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| Ms. tracey melville
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| Vol #:
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| 163
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| EC 2649
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| Coolibar, Inc.
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| Vol #:
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| 163
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| EC 2650
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| Mrs. Deirdre Flanagan
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| Vol #:
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| 163
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| EC 2651
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| Mrs. Beverly Andress
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| Vol #:
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| 163
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| EC 2652
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| Ms. Donna Schmitt
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| Vol #:
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| 163
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| EC 2653
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| Ms. Kelly Jennings
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| Vol #:
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| 163
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| EC 2654
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| Ms. Sheila Bishoff
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| Vol #:
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| 163
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| EC 2655
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| Mrs. Valerie Donahue
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| Vol #:
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| 163
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| EC 2656
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| BASF
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| Vol #:
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| 163
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| EC 2657
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| Ms. Anna Herrera
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| Vol #:
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| 163
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| 2005D-0112
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| Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
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| EC 46
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| Mr. Otis Pannell
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| Vol #:
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| 1
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| EC 47
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| Mr. Marvin Spence
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| Vol #:
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| 1
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| EC 48
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| Mr. R Swearingen
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| Vol #:
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| 1
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| EC 49
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| Mrs. Rosalie Terrill
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| Vol #:
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| 1
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| EC 50
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| Mrs. Lori Irwin
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| Vol #:
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| 1
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| EC 51
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| Mrs. La Donna Springer
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| Vol #:
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| 1
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| 2005D-0490
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| Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)
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| ANS 11
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| FDA/SFSAN to Jesper Korning
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| Vol #:
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| 1
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| ANS 12
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| FDA/CFSAN to Patricia Faison
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| Vol #:
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| 1
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| ELET 12
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| P. Faison
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| Vol #:
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| 1
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 18340
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| R. Strayer
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| Vol #:
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| 198
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| 2005P-0450
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| Revoke the GRAS Status of Salt, Set Ceilings on the Amount of Sodium in Processed Foods, Require a Health Warning on Packaged Salt, and Reduce the Daily Value for Sodium
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| EC 6
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| Marshall University
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| Vol #:
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| 1
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| 2006N-0168
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| Food Labeling: Reference Daily Intakes & Daily Reference Values
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| EC 63
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| Mrs. Carol zizert
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| Vol #:
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| 1
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| EC 64
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| Mrs. Pam Kapustik
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| Vol #:
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| 1
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| EC 65
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| Mrs. Amity Sanders
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| Vol #:
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| 1
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| EC 66
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| Fresenius Medical Care
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| Vol #:
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| 1
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| EC 67
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| Mrs. Jennifer Catalano
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| Vol #:
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| 1
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| EC 68
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| Fresenius Medical Care
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| Vol #:
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| 1
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| EC 69
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| Fresenius Medical Care
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| Vol #:
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| 1
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| EC 70
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| Mr. thomas tio
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| Vol #:
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| 1
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| EC 71
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| Mrs. Lynne Frichtl
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| Vol #:
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| 1
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| EC 72
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| Liberty Dialysis
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| Vol #:
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| 1
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| EC 73
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| Mrs. valerie klave
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| Vol #:
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| 1
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| EC 74
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| FMC Aurora Dialysis
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| Vol #:
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| 1
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| EC 75
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| Ms. Cailie Fura
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| Vol #:
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| 1
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| EC 76
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| University of Illinois
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| Vol #:
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| 1
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| EC 77
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| FMC
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| Vol #:
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| 1
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| EC 78
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| Mrs. Ruth Selbe
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| Vol #:
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| 1
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| EC 79
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| University of Connecticut Health Center
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| Vol #:
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| 1
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| EC 80
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| DaVita
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| Vol #:
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| 1
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| EC 81
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| Registered Dietitian (Renal specialty)
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| Vol #:
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| 1
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| EC 82
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| Fresenius Medical Care DIalysis
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| Vol #:
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| 1
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| EC 83
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| FMC Orland Park Dialysis
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| Vol #:
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| 1
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| EC 84
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| Mrs. Kellie Hochhalter
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| Vol #:
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| 1
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| EC 85
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| Davita Healthcare
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| Vol #:
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| 1
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| EC 86
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| Mrs. Theresa Murray
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| Vol #:
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| 1
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| EC 87
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| Mrs. Joan Mclarry
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| Vol #:
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| 1
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| EC 88
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| Ms. Amy Woods
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| Vol #:
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| 1
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| 2007D-0396
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| Drug-Induced Liver Injury: Premarketing Clinical Evaluation;Draft Guidance
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| C 1
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| St. Vincent Hospital
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| Vol #:
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| 1
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| 2007N-0277
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| Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
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| EC 23
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| General Mills
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| Vol #:
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| 1
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| EC 24
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| General Mills
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| Vol #:
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| 1
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| EC 25
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| International Dairy Foods Association
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| Vol #:
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| 1
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| EC 26
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| American Medical Association
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| Vol #:
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| 1
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| EC 27
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| Dole Food Company
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| Vol #:
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| 1
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| EC 28
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| Nationwide Children's Hospital
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| Vol #:
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| 1
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| EC 29
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| Nutrition for the Future, Inc.
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| Vol #:
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| 1
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| EC 30
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| American Dietetic Association
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| Vol #:
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| 1
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| EC 31
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| Dr. Adam Drewnowski
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| Vol #:
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| 4
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| EC 32
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| National Heart Foundation of Australia
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| Vol #:
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| 4
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| EC 33
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| Nutrient Rich Foods Coalitions
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| Vol #:
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| 4
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| EC 34
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| American Beverage Association
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| Vol #:
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| 4
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| EC 35
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| American Beverage Association
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| Vol #:
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| 4
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| EC 36
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| National Cattlemen's Beef Association
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| Vol #:
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| 4
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| EC 37
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| National Dairy Council
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| Vol #:
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| 4
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| EC 38
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| Dr. Jennifer Shu
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| Vol #:
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| 4
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| 2007N-0343
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| Electronic Nonclinical Study Data Submission; Notice of Pilot Project
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| LET 3
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| Eli Lilly and Company
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| Vol #:
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| 1
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| 2007N-0347
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| Information Technology Strategic Planning; Public Meeting
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| EC 17
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| FDA/OCIO
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| Vol #:
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| 2
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| 2007N-0356
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| BEHIND THE COUNTER AVAILABILITY OF CERTAIN DRUGS; Public Meeting
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| EC 38
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| Dr. Marietta Angelotti
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| Vol #:
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| 2
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| EC 39
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| Dr. Steve Perkins
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| Vol #:
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| 2
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| EC 40
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| Dr. John Bossian
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| Vol #:
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| 2
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| EC 41
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| Dr. Scott Bohner
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| Vol #:
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| 2
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| EC 42
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| DHHS/Division of Health Service Regulation
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| Vol #:
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| 2
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| EC 43
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| Dr. Bergein Overholt
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| Vol #:
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| 2
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| EC 44
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| Dr. Raymond Petrus
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| Vol #:
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| 2
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| EC 45
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| Ada Family Medical Center
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| Vol #:
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| 2
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| EC 46
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| Dr. Greta Ivers
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| Vol #:
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| 2
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| EC 47
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| Maryland Pharmacists Association
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| Vol #:
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| 2
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| EC 48
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| Dr. wade hawkins
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| Vol #:
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| 2
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| EC 49
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| Dr. Glenn Ross
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| Vol #:
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| 2
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| EC 50
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| Resurrection Healthcare
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| Vol #:
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| 2
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| EC 51
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| AAFP
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| Vol #:
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| 2
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| EC 52
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| Kneibert Clinic
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| Vol #:
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| 2
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| EC 53
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| Dr. Janet Green
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| Vol #:
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| 2
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| EC 54
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| central texas pain center
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| Vol #:
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| 2
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| EC 55
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| NACDS
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| Vol #:
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| 2
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| EC 56
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| None
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| Vol #:
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| 2
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| EC 57
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| Dr. Matthew Lewis
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| Vol #:
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| 2
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| 2007N-0382
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| Ramipril Capsules and 180-day generic drug exclusivity
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| ACK 1
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| FDA/DDM to Apotex, Inc.
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| Vol #:
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| 1
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| PSA 1
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| Apotex, Inc.
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| Vol #:
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| 1
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| 2007N-0417
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| Acarbose Tablets and 180-day exclusivity
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| EC 1
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| Mr. Brian Malkin
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| Vol #:
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| 1
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| 2007P-0297
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| Request to reconsider the failure to approve Provenge
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| EC 133
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| Mr. Craig Becker
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| Vol #:
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| 1
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| EC 134
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| Mr. Michael Harmening
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| Vol #:
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| 1
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| 2007P-0320
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| Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
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| EC 20
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| Ms. Deanne Johnson
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| Vol #:
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| 1
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| 2007P-0400
|
| Formally ban unnaturally synthesized fluoride compounds sold for consumption through oral ingestion
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| C 2
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| Palomar College
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| Vol #:
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| 1
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