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| Dockets Entered
On August 16, 2007
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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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-0348
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| Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| 2006D-0079
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| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| 2006N-0104
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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| 2006N-0454
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| Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
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| 2007D-0025
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| Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container; Availability
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| 2007D-0168
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| Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
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| 2007D-0185
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| Guidance for Industry and Review Staff on Labeling for Human Prescription Drugs Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information
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| 2007D-0201
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| Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
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| 2007D-0249
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| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
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| 2007D-0268
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
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| 2007M-0161
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| Premarket Approval for AxSYM AUSAB by Abbott Laboratories, P060003
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| 2007N-0064
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| Electronic Case Report Form Submission; Notice of Pilot Project
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| 2007N-0073
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2007N-0198
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| Medical Devices; General Hospital and Personal Use Devices; Classification of the Filtering facepiece respirator for use by the general public in public health medical emergencies
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| 2007N-0264
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| Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
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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-0305
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| Current Good Manufacturing Practice Regulations for Medicated Feeds; Agency Information Collection Activities
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| 2007N-0306
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| Current Good Manufacturing Practice Regulations for Type A Medicated Articles; Agency Information Collection Activities
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| 2007P-0070
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| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
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| 2007P-0074
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| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 20527
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| Aboca USA Inc.
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| Vol #:
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| 180
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| LET 20528
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| Aboca USA Inc.
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| Vol #:
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| 180
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| LET 20529
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| Aboca USA Inc.
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| Vol #:
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| 180
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| LET 20530
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| Aboca USA Inc.
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| Vol #:
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| 180
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| LET 20531
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| Aboca USA Inc.
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| Vol #:
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| 180
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| LET 20532
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| Aboca USA Inc.
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| Vol #:
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| 180
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| LET 20533
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| Aboca USA Inc.
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| Vol #:
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| 180
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| LET 20534
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| Nexgen Pharma tm, Inc.
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| Vol #:
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| 180
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| LET 20535
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| Nexgen Pharma tm, Inc.
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| Vol #:
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| 180
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| LET 20536
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| Sante' Active
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| Vol #:
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| 180
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| LET 20537
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| Bayer HealthCare LLC Consumer Care Division
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| Vol #:
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| 180
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| LET 20538
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| Bayer HealthCare LLC Consumer Care Division
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| Vol #:
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| 180
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| LET 20539
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 180
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| LET 20540
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 180
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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 43
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| ND. Doctors Protest of new durgs
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| 1
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| 2005D-0348
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| Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order
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| EC 5
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| Mr. Franklin Taylor
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| Vol #:
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| 1
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| 2005N-0272
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| Irradiation in the Production, Processing & Handling of Food
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| C 3745
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| Form Letter Count 6
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| Vol #:
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| 62
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| 2006D-0079
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| Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
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| EC 47
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| private citizen
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| Vol #:
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| 1
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| 2006D-0347
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| Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
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| EC 90
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| Biotechnology Industry Organization
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| Vol #:
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| 2
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| EC 91
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| Washington University School of Medicine
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| Vol #:
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| 2
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| 2006N-0104
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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| EC 4
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| Surgical Migraine Clinic
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| Vol #:
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| 1
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| EC 5
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| Laboratorios Feltrex
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| Vol #:
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| 1
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| EC 6
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| Mr. :Ronald :Schulz
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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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| EC 20
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| American Society of Health-System Pharmacists
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| Vol #:
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| 1
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| EC 21
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| Academy of Managed Care Pharmacy
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| Vol #:
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| 1
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| EC 22
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| Cystic Fibrosis Foundation
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| Vol #:
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| 1
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| EC 23
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| Henry Ford Health System
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| Vol #:
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| 1
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| EC 24
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| Mr. Robert McClearen
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| Vol #:
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| 1
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| EC 25
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| Ms. Eva Herr
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| Vol #:
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| 1
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| EC 26
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| Mr. James Weaver
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| Vol #:
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| 1
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| EC 27
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| The National Orhanization Of Asthma And COPD Patie
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| Vol #:
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| 1
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| 2007D-0025
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| Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container; Availability
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| EC 3
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| HemoGenix, Inc
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| Vol #:
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| 2
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| EC 4
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| Ms. Sandra Nelson
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| Vol #:
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| 2
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| 2007D-0117
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| Guidance for Industry on Orally Disintegrating Tablets
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| C 12
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| Catalent
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| Vol #:
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| 1
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| 2007D-0168
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| Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
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| EC 1
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| Surgical migraine clinic
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| Vol #:
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| 1
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| 2007D-0185
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| Guidance for Industry and Review Staff on Labeling for Human Prescription Drugs Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information
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| EC 1
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EC 2
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| Pharm Res
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| Vol #:
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| 1
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| EC 3
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| Dr. Richard Gural
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| Vol #:
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| 1
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| EC 4
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| Eli Lilly and Company
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| Vol #:
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| 1
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| EC 5
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| Merck Research Laboratories
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| Vol #:
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| 1
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| EC 6
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| Genzyme Corp.
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| Vol #:
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| 1
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| 2007D-0201
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| Guidance for Industry and Food and Drug Administration Staff; Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents
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| EC 1
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| Surgical migraine clinic
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| Vol #:
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| 1
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| 2007D-0249
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| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
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| EC 2
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| private citizen
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| Vol #:
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| 1
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| |
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| 2007D-0268
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| Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology
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| EC 2
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| Mrs. barbara white
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| Vol #:
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| 1
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| EC 3
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| Ms. Marjorie Moss
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| Vol #:
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| 1
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| 2007M-0161
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| Premarket Approval for AxSYM AUSAB by Abbott Laboratories, P060003
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| AAV 1
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2007N-0064
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| Electronic Case Report Form Submission; Notice of Pilot Project
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| EC 1
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| Raining Data
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| Vol #:
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| 1
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| 2007N-0073
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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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-0198
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| Medical Devices; General Hospital and Personal Use Devices; Classification of the Filtering facepiece respirator for use by the general public in public health medical emergencies
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| BKG 1
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| Background
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| Vol #:
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| 1
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| NFR 1
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| FDA
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| Vol #:
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| 1
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| 2007N-0264
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| Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
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| NFR 1
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| FDA
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| Vol #:
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| 1
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| NPR 1
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| FDA
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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 4
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| Mr. CAZIER OBERHANSLY
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| Vol #:
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| 1
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| 2007N-0305
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| Current Good Manufacturing Practice Regulations for Medicated Feeds; Agency Information Collection Activities
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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-0306
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| Current Good Manufacturing Practice Regulations for Type A Medicated Articles; Agency Information Collection Activities
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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-0070
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| Make fluoride a prescription drug for use in tooth application, tooth paste, and in bottled water
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| EC 47
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| Mrs. Brenda Moore
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| Vol #:
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| 1
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| EC 48
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| Mrs. christine tabrizi
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| Vol #:
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| 1
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| EC 49
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| private citizen
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| Vol #:
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| 1
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| EC 50
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| Ms. Kristi Gabriel
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| Vol #:
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| 1
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| 2007P-0074
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| Take specific action with respect to 21 CFR 341, the Final Monograph for Cough, Cold Allergy, Bronchodilator, Antiasthmatic Drug Products for Over-the-Counter Human Use
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| NM 1
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| FDA
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| Vol #:
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| 1
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| 2007P-0282
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| Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
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| EC 4
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| UVM GIV Camp
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| Vol #:
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| 1
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