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| Dockets Entered
On April 26, 2006
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| Docket #
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| Title
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| 2005D-0011
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| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| 2005D-0392
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| Guidance: Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System
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| 2005D-0412
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| Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicle
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| 2005D-0434
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| Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens
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| 2005D-0438
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| Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
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| 2005D-0481
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| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
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| 2005D-0483
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| Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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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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| 2005N-0404
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| Solicitation of Public Review and Comment on Research Protocol:
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| 2005N-0437
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| Medical Gas Containers and Closures; Current Good Manufacturing
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| 2005N-0444
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| Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient
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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-0436
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| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| 2005P-0441
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| Reservoir Systems for Transdermal Delivery
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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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| 2005P-0462
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| Initiate a Transfer of Regulatory and Classification Responsibilities over Mercury Amalgam
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| 2006P-0174
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| FDA to determine that any drug is therapeutically equivalent or AB-rated to BiDil (isosorbide dinitrate and hydralazine hydrochloride
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| 2006V-0153
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| Variance for Hair Removal System
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| 2003D-0386
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| Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
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| EC 2
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| genpharma laboratoires
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| Vol #:
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| 1
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| EC 3
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| Barry University
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| Vol #:
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| 1
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| 2004N-0408
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| Regulatory Site Visit Training Program
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| LET 6
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| National Institutes of Health (NIH)
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| Vol #:
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| 1
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| REF 1
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| OMB Review for Current Good Manufacturing Practices for Positron Emission Tomography;Proposed
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| Vol #:
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| 2
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| REF 2
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| OMB Review for January 24, 2006
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| Vol #:
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| 3
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| 2005D-0011
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| Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products
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| C 6
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| Schering-Plough
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| Vol #:
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| 1
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| 2005D-0286
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| Draft Guidance for Industry on INDs Approaches to Complying with CGMP During Phase 1; Availability
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| EC 1
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| Novartis Pharmaceutical Corp.
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| Vol #:
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| 1
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| 2005D-0392
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| Guidance: Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System
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| EC 1
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| Dr. Herbert Mooney
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| Vol #:
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| 1
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| 2005D-0412
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| Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicle
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| EC 3
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| Mrs. Jeanne Govert
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| Vol #:
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| 1
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| 2005D-0434
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| Guidance for Industry and Food and Drug Administration; Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens
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| EC 1
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| Cepheid
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| Vol #:
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| 1
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| EC 2
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| Cepheid
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| Vol #:
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| 1
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| EC 3
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| Advanced Medical Technology Association
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| Vol #:
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| 1
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| EC 4
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| Affymetrix, Inc
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| Vol #:
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| 1
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| 2005D-0438
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| Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
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| EC 2
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| ZLB Behring
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| Vol #:
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| 1
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| 2005D-0481
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| Guidance for Industry, Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy, Availability; and draft supporting document, Supporting Do
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| C 11
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| Honorable Jeff Bingaman
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| Vol #:
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| 1
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| EC 4
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| Mr. Thomas Neltner
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| Vol #:
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| 1
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| EC 5
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| Office of the Illinois Attorney General
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| Vol #:
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| 1
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| EC 6
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| Chocolate Mfgs Association
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| Vol #:
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| 1
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| EC 7
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| National Confectioners Association
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| Vol #:
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| 1
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| EC 8
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| Center for Environmental Health
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| Vol #:
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| 1
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| EC 9
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| Center for Policy Analysis on Trade and Health
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| Vol #:
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| 1
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| EC 10
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| Center for Policy Analysis on Trade and Health
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| Vol #:
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| 1
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| 2005D-0483
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| Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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| EC 6
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| Ms. Betty Jung
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| Vol #:
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| 1
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| EC 7
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| Mr. Wayne Gorsek
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| Vol #:
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| 1
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| EC 8
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| Mrs. Jessica Novik
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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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| EC 11
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| Ms. K Tingley
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| Vol #:
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| 1
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| EC 12
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| Purity Foods, Inc.
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| Vol #:
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| 1
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| EC 13
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| Ms. Amberly Van Arnum
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| Vol #:
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| 1
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| C 7227
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| A. Pape
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| Vol #:
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| 114
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| C 7228
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| T. Peterson
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| Vol #:
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| 114
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| C 7229
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| B. Clark
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| Vol #:
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| 114
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| C 7230
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| D. Graves
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| Vol #:
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| 114
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| C 7231
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| C. Arthur
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| Vol #:
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| 114
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| C 7232
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| L. Borthwick
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| Vol #:
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| 114
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| C 7233
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| V. Pierce
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| Vol #:
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| 114
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| C 7234
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| R. Roussera
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| Vol #:
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| 114
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| C 7235
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| P. Burcham
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| Vol #:
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| 114
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| C 7236
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| M. Taylor
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| Vol #:
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| 114
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| C 7237
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| C. Lee
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| Vol #:
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| 114
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| C 7238
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| R. Coit
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| Vol #:
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| 114
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| C 7239
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| C. Owens
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| Vol #:
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| 114
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| C 7240
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| J. Hinkle
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| Vol #:
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| 114
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| C 7241
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| B. Wilbee
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| Vol #:
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| 114
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| C 7242
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| D. Cataline
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| Vol #:
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| 114
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| C 7243
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| S. Rich
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| Vol #:
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| 114
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| C 7244
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| K. Marlow
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| Vol #:
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| 114
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| C 7245
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| B. Scothorn
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| Vol #:
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| 114
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| C 7246
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| A. Buck
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| Vol #:
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| 114
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| C 7247
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| C. Kingsley
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| Vol #:
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| 114
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| C 7248
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| B. Moran
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| Vol #:
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| 114
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| C 7249
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| Dr. Anita Williamson
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| Vol #:
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| 114
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| C 7250
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| C. W. Cappo
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| Vol #:
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| 114
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| C 7251
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| J. Medeiros
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| Vol #:
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| 114
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| C 7252
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| J. Arbisi
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| Vol #:
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| 114
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| 2005P-0436
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| ADA 21-863' Ibuprogen Liquid filled gelatin capsules 200 mg; Ranbaxy Laboratories, Ltd.
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| LET 2
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| FDA/CDER to Frommer Lawrence & Haug LLP
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| Vol #:
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| 1
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| 2005P-0441
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| Reservoir Systems for Transdermal Delivery
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| LET 1
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| FDA/CDER to Gordon L. Flynn, Ph.D.
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| Vol #:
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| 1
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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 3
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| Tufts University
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| Vol #:
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| 1
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| EC 4
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| Mr. Art Cameron
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| Vol #:
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| 1
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| 2005P-0462
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| Initiate a Transfer of Regulatory and Classification Responsibilities over Mercury Amalgam
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