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| Dockets Entered
On December 15, 2004
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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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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 2000N-0504
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| Egg Safety Action Plan
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| 2003D-0380
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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| 2004D-0377
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| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
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| 2004D-0378
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| International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
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| 2004D-0410
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| Application User Fees for Combination Products
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| 2004D-0414
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| FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
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| 2004D-0431
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| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
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| 2004D-0438
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| Guidance for Industry: Use of Material from BSE-Positive Cattle in Animal Feed
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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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| 2004D-0453
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| Compliance Policy Guide Sec. 560.400 - "Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)"
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| 2004D-0466
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| Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
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| 2004D-0499
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| Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs
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| 2004N-0033
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| Factor VIII Inhibitors
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| 2004N-0432
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| Radioactive Drugs for Certain Research Uses; Public Meeting
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| 2004N-0458
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| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
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| 2004P-0266
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| Take immediate action to cease the unlawful distribution of misbranded, adulterated and unlabeled cosmetics.
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| 2004P-0506
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| fentanyl transdermal products reduce the potential for abuse of certain types of these products
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| 2004P-0550
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| Determine that AstraZeneca LP's Xylocaine (lidocaine) 10% Oral Spray (NDA 14-394) was voluntarily withdrawn or withheld from sale for reasons other than safety or effficacy
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| 2004S-0233
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| Stimulating Innovation in Medical Technologies
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| 2004V-0508
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| Projector for a Laser Light Show
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| 2004V-0521
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| Laser Light Show
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| 2004V-0547
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| Laser Light Show
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| 2004V-0548
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| Projector for a Laser Light Show
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| |
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
15008
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| NOW Foods
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| Vol #:
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| 132
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| LET
15009
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| NOW Foods
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| Vol #:
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| 132
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| LET
15010
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| NOW Foods
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| Vol #:
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| 132
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| LET
15011
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| NOW Foods
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| Vol #:
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| 132
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| LET
15012
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| Covaxil TM Laboratories, LLC
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| Vol #:
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| 132
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| LET
15013
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| A. G. Waterhouse TM, LLC
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| Vol #:
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| 132
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| LET
15014
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| Dynakor Pharmacal TM, LLC
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| Vol #:
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| 132
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| LET
15015
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| Nutrition for Two TM, LLC
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| Vol #:
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| 132
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| LET
15016
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| Enzymatic Therapy
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| Vol #:
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| 132
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| LET
15017
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| Source Naturals
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| Vol #:
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| 133
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| LET
15018
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| Your Vitamins Andrew Lessman
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| Vol #:
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| 133
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| LET
15019
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| Your Vitamins Andrew Lessman
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| Vol #:
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| 133
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| LET
15020
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| Celestial Seasonings
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| Vol #:
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| 133
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| LET
15021
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| Oriental Chinese Herbs Pharmaceutical Ltd.
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| Vol #:
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| 133
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| LET
15022
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| Your Vitamins Andrew Lessman
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| Vol #:
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| 133
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| LET
15023
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| Your Vitamins Andrew Lessman
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| Vol #:
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| 133
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| LET
15024
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| Weleda
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| Vol #:
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| 133
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| LET
15025
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| North American Pharmacal Inc.
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| Vol #:
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| 133
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| LET
15026
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| Herbal Science
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| Vol #:
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| 133
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| LET
15027
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| Enzymatic Therapy
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| Vol #:
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| 133
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| LET
15028
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| Enzymatic Therapy
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| Vol #:
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| 133
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| LET
15029
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| Enzymatic Therapy
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| Vol #:
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| 133
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| LET
15030
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| Source Naturals
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| Vol #:
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| 133
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| LET
15031
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| Generix Laboatories TM, LLC
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| Vol #:
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| 133
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| LET
15032
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| Ajinomoto Corporate Services LLV
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| Vol #:
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| 133
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| LET
15033
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| Ajinomoto Corporate Services LLC
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| Vol #:
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| 133
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| C 7465
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| V. Lamarche
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| Vol #:
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| 319
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| 2000N-0504
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| Egg Safety Action Plan
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| C
180
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| Konos Inc.---Vande Bunte Eggs
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| Vol #:
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| 19
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| C 181
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| J. Maclean
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| Vol #:
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| 19
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| C 182
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| C. Boeck
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| Vol #:
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| 19
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| C 183
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| D. Bolbol
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| Vol #:
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| 19
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| C
184
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| University of Minnesota
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| Vol #:
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| 19
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| C 185
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| D. Lathem
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| Vol #:
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| 19
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| C 186
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| C. Emerson
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| Vol #:
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| 19
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| C
187
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| Kofkoff Egg Farms
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| Vol #:
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| 19
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| C 188
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| J. Alexander
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| Vol #:
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| 19
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| C 189
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| J. Welch
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| Vol #:
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| 19
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| C 190
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| L. Thompson
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| Vol #:
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| 19
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| C 191
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| N. Gill
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| Vol #:
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| 19
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| |
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| 2003D-0229
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| Draft Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
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| EC 2
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| Mr. Mike Muszynski
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| Vol #:
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| 1
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| 2003D-0380
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| Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability
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| EC 5
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| taxpayer
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| Vol #:
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| 3
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| 2003D-0554
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| Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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| EC
7
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| National Association of Beverage Importers, Inc.
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| Vol #:
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| 1
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| EC
8
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| National Association of Beverage Importers, Inc.
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| Vol #:
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| 1
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| CS
12
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| HFA-305
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| Vol #:
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| 6
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| OR
11
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| HF-3
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| Vol #:
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| 6
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| RMO
3
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| GCF-1
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| Vol #:
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| 6
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| 2004D-0028
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| Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
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| EC 10
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| Ms. Elizabeth Dispennett
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| Vol #:
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| 1
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| 2004D-0343
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| Hospital Bed System Dimensional Guidance to Reduce Entrapment
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| EC
49
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| Genesis Medical Center
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| Vol #:
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| 2
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| EC
50
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| Syringa General Hospital
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| Vol #:
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| 2
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| EC
51
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| Newport Hospital
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| Vol #:
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| 2
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| EC
52
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| Genesis Medical Center
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| Vol #:
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| 2
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| EC
53
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| Memorial Health Care
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| Vol #:
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| 2
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| EC
54
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| Ephraim McDowell Regional Medical Center
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| Vol #:
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| 2
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| EC
55
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| University of Wisconsin Hospital and Clinics
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| Vol #:
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| 2
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| EC
56
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| Kendal Outreach, LLC
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| Vol #:
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| 2
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| EC
57
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| ICCG/Carroll Healthcare/Carroll Hospital Group
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| Vol #:
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| 2
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| EC
58
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| Athens Regional Medical Center
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| Vol #:
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| 2
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| EC
59
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| Advocate Illinois Masonic Medical Center
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| Vol #:
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| 2
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| EC
60
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| Saint Agnes Medical Center
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| Vol #:
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| 2
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| EC
61
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| American Society for Healthcare Engineering
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| Vol #:
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| 2
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|
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| EC
62
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| M.C. Healthcare Products
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| Vol #:
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| 2
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|
|
|
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| 2004D-0377
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| International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
|
|
|
|
|
|
|
|
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| EC
6
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| Duke Clinical Research Institute - Duke Univ.
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| Vol #:
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| 1
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| | | | | | | | |
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| |
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| EC
7
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| Pfizer Inc
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| Vol #:
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| 1
|
|
|
|
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| 2004D-0378
|
| International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
|
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| C
1
Attachment
1, 2
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| Merck & Co., Inc.
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| Vol #:
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| 1
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| C
2
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| AstraZeneca Pharmaceuticals, LP
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| Vol #:
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| 1
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| C
3
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| Schering-Plough
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| Vol #:
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| 1
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| EC
2
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| GlaxoSmithKline
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| Vol #:
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| 1
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| EC
3
Attachment
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| Pfizer Inc
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| Vol #:
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| 1
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| EXT
1
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| Wyeth Pharmaceuticals
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| Vol #:
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| 1
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|
|
|
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| 2004D-0410
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| Application User Fees for Combination Products
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| EC
1
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| Pharmaceutical Research and Manufacturers of Ameri
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| Vol #:
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| 1
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| EC
2
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| Cook Group, Inc.
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| Vol #:
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| 1
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| EC
3
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| AdvaMed
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| Vol #:
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| 1
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|
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|
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| EC
4
|
| Medtronic Inc
|
| Vol #:
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| 1
|
|
|
|
|
| 2004D-0414
|
| FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
|
|
|
|
|
| EC
1
|
| Ivioce Inc.
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| Vol #:
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| 1
|
|
|
|
|
| 2004D-0431
|
| Draft Guidance for Industry: Current Good Manufacturing Practices for Combination Products
|
|
|
| C
10
|
| Cambrex BioScience Walkersville, Inc.
|
| Vol #:
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| 1
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| C
11
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| Advanced Medical Technology Assn (AdvaMed)
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| Vol #:
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| 1
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| EC 1
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| Dr. Drudge Boy
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| Vol #:
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| 1
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| EC
2
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| Eli Lilly and Company
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| Vol #:
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| 1
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| EC
3
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| American Medical Systems
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| Vol #:
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| 1
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| EC
4
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| Pfizer Inc.
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| Vol #:
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| 1
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|
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| EC
5
|
| Combination Products Coalition
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| Vol #:
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| 1
|
|
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|
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| EC
6
|
| Cook Group, Inc.
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| Vol #:
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| 1
|
|
|
|
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| EC
7
|
| Amgen Inc.
|
| Vol #:
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| 1
|
|
|
|
|
| 2004D-0438
|
| Guidance for Industry: Use of Material from BSE-Positive Cattle in Animal Feed
|
|
|
|
|
| EC 1
|
| Miss. Paola Pannucci
|
| Vol #:
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| 1
|
|
|
|
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| EC 2
|
| Mr. Donald Gray
|
| Vol #:
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| 1
|
|
|
|
|
| 2004D-0443
|
| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
|
|
|
|
|
| C
14
|
| Japan Society of Pharmaceutical Machinery and Engineering (JSPME)
|
| Vol #:
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| 2
|
|
|
|
|
| C
15
|
| European Federation of Pharmaceutical Industries and Associations (EFPIA)
|
| Vol #:
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| 2
|
|
|
|
|
| EC
3
|
| Compressed Gas Association
|
| Vol #:
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| 2
|
|
| | | | | | | | |
|
| |
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| EC
4
|
| Pfizer
|
| Vol #:
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| 2
|
|
|
|
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| EC
5
Attachment
|
| Alcon, Inc.
|
| Vol #:
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| 2
|
|
|
|
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| EC
6
|
| Wells
|
| Vol #:
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| 2
|
|
|
|
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| EC
7
Attachment
|
| EFPIA
|
| Vol #:
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| 2
|
|
|
|
|
| EC
8
|
| AABB
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004D-0453
|
| Compliance Policy Guide Sec. 560.400 - "Imported Milk and Cream Federal Import Milk Act (CPG 7119.05)"
|
|
|
|
|
| C
3
|
| O-AT-KA Milk Products Cooperative, Inc.
|
| Vol #:
|
| 1
|
|
|
|
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| C
4
|
| Upstate Farms Cooperative, Inc.
|
| Vol #:
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| 1
|
|
|
|
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| C
5
|
| American Dairy Products Institute (ADPI)
|
| Vol #:
|
| 1
|
|
|
|
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| EC
1
|
| Keller and Heckman LLP
|
| Vol #:
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| 1
|
|
|
|
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| EC
2
|
| National Milk Producers Federation
|
| Vol #:
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| 1
|
|
|
|
|
| EC
3
|
| International Dairy Foods Association
|
| Vol #:
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| 1
|
|
|
|
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| EC
4
|
| National Farmers Union
|
| Vol #:
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| 1
|
|
|
|
|
| EC
5
|
| California Farmers Union
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
6
|
| California Dairy Campaign
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0466
|
| Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act
|
|
|
|
|
| EC
1
|
| Diverstech Co.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004D-0499
|
| Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs
|
|
|
|
|
| C
3
|
| Secure Sumbology, Inc. (SSI)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0033
|
| Factor VIII Inhibitors
|
|
|
|
|
| EC 4
|
| Mr. John Rizzo
|
| Vol #:
|
| 4
|
|
|
|
|
| 2004N-0432
|
| Radioactive Drugs for Certain Research Uses; Public Meeting
|
|
|
| EC
1
|
| Kettering Medical Center
|
| Vol #:
|
| 1
|
|
|
|
|
| EC
2
|
| Massachusetts General Hospital / MIT
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0458
|
| Dietary Supplements; Regulatory Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994
|
|
|
|
|
| EC 2
|
| Dr. Elizabeth Lipski, PhD, CCN
|
| Vol #:
|
| 1
|
|
|
|
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| EC 3
|
| Dr. Joseph Anticoli
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| Vol #:
|
| 1
|
|
|
|
|
| EC 4
|
| Miss. Janiel Burke
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| Vol #:
|
| 1
|
|
|
|
|
| EC 5
|
| Mr. Jeffery Noren
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| Vol #:
|
| 1
|
|
|
|
|
| EC 6
|
| Dr. Roger Effinger
|
| Vol #:
|
| 1
|
|
|
|
|
| EC 7
|
| Miss. abigail rolfe
|
| Vol #:
|
| 1
|
|
| |
|
| 2004P-0266
|
| Take immediate action to cease the unlawful distribution of misbranded, adulterated and unlabeled cosmetics.
|
|
| | | | | | | | |
|
| |
|
| LET
1
|
| HFS-100 to Environmental Working Group
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0506
|
| fentanyl transdermal products reduce the potential for abuse of certain types of these products
|
|
|
|
|
| C
1
|
| Mylan Technologies, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2004P-0550
|
| Determine that AstraZeneca LP's Xylocaine (lidocaine) 10% Oral Spray (NDA 14-394) was voluntarily withdrawn or withheld from sale for reasons other than safety or effficacy
|
|
|
|
|
| ACK
1
|
| HFA-305 to Arent Fox
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Arent Fox
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004S-0233
|
| Stimulating Innovation in Medical Technologies
|
|
|
|
|
| EC
18
|
| AABB
|
| Vol #:
|
| 2
|
|
|
|
|
| EC
19
|
| Infectious Diseases Society of America
|
| Vol #:
|
| 2
|
|
|
|
|
| EC
20
|
| Medical Device Manufacturers Association
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004V-0508
|
| Projector for a Laser Light Show
|
|
|
|
|
| VRA
1
|
| HFZ-300 to Jake Barner Studios
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004V-0521
|
| Laser Light Show
|
|
|
|
|
| VRA
1
|
| HFA-300 to Hot Wax Unlimited
|
| Vol #:
|
| 1
|
|
| |
|
| 2004V-0547
|
| Laser Light Show
|
|
|
|
|
| ACK
1
|
| HFA-305 t0 Tinsletown 17
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR
1
|
| Tinsletown 17
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004V-0548
|
| Projector for a Laser Light Show
|
|
|
|
|
| ACK
1
|
| HFA-305 to Mezzanotte LLC
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR
1
|
| Mezzanotte LLC
|
| Vol #:
|
| 1
|
|
