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| Dockets Entered
On June 1, 2004
Table of Contents
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| Docket
#
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| Title
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| 1995P-0241
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| Implied Nutrient Content Claim "Healthy" & Health Claims
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 2000D-1350
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| Combined Oral Contraceptives/Labeling/Healthcare Providers
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| 2003N-0324
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| New Animal Drugs; Removal of Obsolete and Redundant Regulations
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2004D-0117
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| International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
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| 2004D-0118
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| International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
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| 2004D-0187
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| Guidance for Industry on Premarketing Risk Assessment
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
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| 2004D-0189
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| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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| 2004N-0087
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| Request for Comment on Generic Drug Issues
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| 2004N-0101
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents; and Requiremen
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| 2004N-0133
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| Part 11, Electronic Record; Electronic Signatures; Public Meeting
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| 2004N-0194
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| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
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| 2004N-0221
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| 1994P-0390
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| Adopt Amendments Governing Health Claims & Nutrient Claims
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| EMC 1
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| B. Sachau
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| Vol #:
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| 5
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| 1995P-0241
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| Implied Nutrient Content Claim "Healthy" & Health Claims
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| EMC 1
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| B. Sachau
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| Vol #:
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| 5
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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| EMC 4232
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| H. Braun
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| Vol #:
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| 304
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| EMC 4233
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| H. Braun
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| Vol #:
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| 304
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| EMC 4234
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| T. Laos
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| Vol #:
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| 304
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| EMC 4235
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| S. Romdenne
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| Vol #:
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| 304
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| EMC 4236
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| M. Seymour
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| Vol #:
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| 304
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| EMC 4216
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| K. Edwards
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| Vol #:
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| 515
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| EMC 4217
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| B. Sessley
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| Vol #:
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| 515
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| EMC 535
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| L. Anderson
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| Vol #:
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| 24
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| EMC 536
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| L. LaLonde
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| Vol #:
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| 24
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| EMC 537
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| L. Tremaine
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| Vol #:
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| 24
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| EMC 162
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| Nellie
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| Vol #:
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| 304
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| 2000D-1350
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| Combined Oral Contraceptives/Labeling/Healthcare Providers
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| EMC
5
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| Johnson and Johnson
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| Vol #:
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| 6
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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| EXB 39
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| CVM
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| Vol #:
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| 406
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| EXB 40
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| CVM
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| Vol #:
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| 406
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| EXB 41
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| CVM
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| Vol #:
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| 406
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| EXB 42
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| CVM
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| Vol #:
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| 406
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| EXB 43
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| CVM
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| Vol #:
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| 406
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| EXB 44
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| CVM
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| Vol #:
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| 406
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| EXB 45
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| CVM
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| Vol #:
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| 407
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| EXB 46
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| CVM
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| Vol #:
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| 407
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| EXB 47
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| CVM
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| Vol #:
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| 407
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| EXB 48
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| CVM
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| Vol #:
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| 407
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| EXB 49
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| CVM
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| Vol #:
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| 407
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| EXB 50
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| CVM
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| Vol #:
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| 407
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| EXB 51
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| CVM
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| Vol #:
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| 407
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| CP
2
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| Pharmacists planning service, Inc
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| Vol #:
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| 19
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1234
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| K. Corrie
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| Vol #:
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| 5
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| EMC 1235
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| C. Graham
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| Vol #:
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| 5
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| EMC 202
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| L. Thorvaldson
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| Vol #:
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| 25
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC
334
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| Mission Possible Intl
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| Vol #:
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| 6
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| EMC
335
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| Mission Possible Intl
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| Vol #:
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| 6
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 183
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| S. Andree
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| Vol #:
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| 7
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| EMC 184
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| M. Riebel
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| Vol #:
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| 7
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| EMC 185
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| S. Slaughter
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| Vol #:
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| 7
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| EMC 186
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| J. Shands
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| Vol #:
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| 7
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| EMC
187
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| Yale University School of Medicine
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| Vol #:
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| 7
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| EMC 188
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| V. Kovach
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| Vol #:
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| 7
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| EMC 189
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| V. Cox
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| Vol #:
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| 7
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| EMC 190
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| D. Perrault, MD
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| Vol #:
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| 7
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| EMC 191
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| L. Kelsey
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| Vol #:
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| 7
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| EMC 192
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| L. Kelsey
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| Vol #:
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| 7
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| 2003N-0324
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| New Animal Drugs; Removal of Obsolete and Redundant Regulations
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| EMC 2
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| L. Feather, RPh
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| Vol #:
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| 1
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| 2003N-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| EMC 51
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| No signature
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| Vol #:
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| 15
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|
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| 2004D-0117
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| International Conference on Harmonisation; Draft Guidance on E2E Pharmacovigilance Planning
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| EMC 1
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| R. Reinhard
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| Vol #:
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| 1
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| EMC
2
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| Merck & Co., Inc.
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| Vol #:
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| 1
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| EMC
3
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| EMC
4
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| Plasma Protein Therapeutics Assn (PPTA)
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| Vol #:
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| 1
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| 2004D-0118
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| International Conference on Harmonisation; Draft Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
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| EMC
1
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| Merck & Co., Inc.
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| Vol #:
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| 1
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| EMC
2
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| Biotechnolgy Industry Organization (BIO)
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| Vol #:
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| 1
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| 2004D-0187
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| Guidance for Industry on Premarketing Risk Assessment
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| EMC 1
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| T. Scherer
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| Vol #:
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| 1
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|
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| 2004D-0188
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| Guidance for Industry on Development and Use of Risk Minimization Action Plans
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| | | | | | | | |
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| EMC 1
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| T. Scherer
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| Vol #:
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| 1
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|
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| 2004D-0189
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| Guidance for Industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
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| EMC 1
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| T. Scherer
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| Vol #:
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| 1
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| 2004N-0087
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| Request for Comment on Generic Drug Issues
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| EMC
3
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| Biotechnology Industry Organization (BIO)
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| Vol #:
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| 1
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| 2004N-0101
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents; and Requiremen
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| EMC
1
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| America's Blood Centers
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| Vol #:
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| 1
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| 2004N-0133
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| Part 11, Electronic Record; Electronic Signatures; Public Meeting
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| EMC 7
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| R. Senecal
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| Vol #:
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| 1
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| EMC
8
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| IDS Scheer AG
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| Vol #:
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| 1
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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| 2004N-0194
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| DEFINITION OF PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT
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| EMC 1
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| R. Fucetola, JD
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| Vol #:
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| 1
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| 2004N-0221
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
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| EMC 1
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| D. Quietwater
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| Vol #:
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| 1
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| 2004N-0230
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| Food; Current Good Manufacturing Practice Regulations; Public Meetings
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| EMC 1
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| B. Sachau
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| Vol #:
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| 1
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