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3
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CVM GFI #3 General Principles for Evaluating the Safety of Compounds Used in Food Producing Animals (PDF - 223KB)
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07/27/06
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5
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CVM GFI #5 Stability Guidelines (PDF - 385KB)
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12/01/90
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6
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CVM GFI #6 Submitting NADA's for Generic Drugs Reviewed by NAS/NR
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03/19/76
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13
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CVM GFI #13 Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds-Medicated Block
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01/01/85
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23
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CVM GFI #23 Medicated Free Choice Feeds--Manufacturing Control
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07/01/85
|
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24
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CVM GFI #24 Drug Combinations for Use in Animals
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10/01/83
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35
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CVM GFI #35 Bioequivalence Guidance (PDF - 182KB)
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11/08/06
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37
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CVM GFI #37 Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for Pigmentation
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03/01/84
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38
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CVM GFI #38 Guideline for Effectiveness Evaluation of Topical/Otic Animal Drugs
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03/01/84
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40
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CVM GFI #40 Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drug Combinations in Poultry (PDF - 2.5MB)
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04/01/92
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42
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CVM GFI #42 Animal Drug Manufacturing Guidelines- Series of Four Guidelines
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01/01/94
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45
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CVM GFI #45 Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle
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08/01/93
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49
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CVM GFI #49 Target Animal Safety And Drug Effectiveness Studies for Anti-Microbial Bovine Mastitis Products (Lactating and Non-Lactating Cow Products)
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04/01/96
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50
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CVM GFI #50 Target Animal and Human Food Safety,Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products
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02/01/93
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53
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CVM GFI #53 Evaluation of the Utility of Food Additives in Diet Fed to Aquatic Animals
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05/01/94
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55
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CVM GFI #55 Supportive Data for Cat Food Labels Bearing "Reduces Urinary pH Claims: Protocol Development
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06/01/94
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56
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CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials (PDF - 60KB)
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07/10/01
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57
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CVM GFI #57 Preparation and Submission of Veterinary Master Files (PDF - 51KB)
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01/01/95
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61
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CVM GFI #61 FDA Approval of New Animal Drugs for MUMS (PDF - 432KB)
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05/29/08
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|
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CVM GFI #62 Consumer Directed Broadcast Advertisements
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08/01/99
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63
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VICH GL1 - Validation of Analytical Procedures: Definition and Terminology (PDF - 65KB)
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07/01/99
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64
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VICH GL2 - Validation of Analytical Procedures: Methodology: Final Guidance (PDF - 168KB)
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07/01/99
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|
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CVM GFI #65 Industry Supported Scientific and Educational Activities (PDF - 428KB)
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11/01/97
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67
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CVM GFI #67 Small Entities Compliance Guide for Renderers (PDF - 66KB)
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02/01/98
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68
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CVM GFI #68 Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors (PDF - 66KB)
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02/01/98
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69
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CVM GFI #69 Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations (PDF - 62KB)
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02/01/98
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70
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CVM GFI #70 Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations (PDF - 59KB)
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07/13/09
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72
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CVM GFI #72 GMP'S For Medicated Feed Manufacturers Not Required to Register and be Licensed with FDA (PDF - 57KB)
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05/01/98
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73
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VICH GL3(R) - Stability Testing Of New Veterinary Drug Substances (PDF - 228KB)
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11/21/07
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74
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VICH GL4 - Stability Testing of New Veterinary Dosage Forms (PDF - 65KB)
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05/01/99
|
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75
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VICH GL5 -Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products (PDF - 76KB)
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05/01/99
|
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76
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CVM GFI #76 Questions and Answers BSE Feed Regulations (PDF - 142KB)
|
01/01/98
|
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79
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CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM (PDF - 61KB)
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07/01/05
|
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80
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CVM GFI #80 Evaluation the Utility of Anti-Salmonella Chemical Food Additives (PDF - 78KB)
|
11/21/02
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82
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CVM GFI #82 Development of Supplemental Applications for Approved New Animal Drugs (PDF - 238KB)
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10/28/02
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83
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CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA (PDF - 162KB)
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05/30/07
|
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85
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VICH GL9 - Good Clinical Practices (PDF - 260KB)
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05/09/01
|
|
89
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VICH GL6 - EIA's for Veterinary Medicinal Products - Phase I (PDF - 106KB)
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03/07/01
|
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90
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VICH GL7 - Effectiveness of Anthelmintics: General Recommendations (PDF - 64KB)
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10/11/01
|
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91
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VICH GL8 - Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products on Stability Testing for Medicated Premixes (PDF - 33KB)
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03/01/00
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92
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VICH GL10(R) - Impurities In New Veterinary Drug Substances (PDF - 176KB)
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11/21/07
|
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93
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VICH GL11(R) - Impurities in New Veterinary Medicinal Products (PDF - 196KB)
|
11/21/07
|
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95
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VICH GL12 - Efficacy of Anthelmintics: Specific Recommendations for Bovines (PDF - 65KB)
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03/26/01
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96
|
VICH GL13 - Efficacy of Anthelmintics: Specific Recommendations for Ovines (PDF - 58KB)
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03/26/01
|
|
97
|
VICH GL14 - Efficacy of Anthelmintics: Specific Recommendations for Caprines (PDF - 66KB)
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03/26/01
|
|
98
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CVM GFI #98 Dioxin In Anti-Caking Agents In Animal Feed And Feed Ingredients (PDF - 35KB)
|
04/12/00
|
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99
|
VICH GL17 - Testing of New Biotechnological/Biological Products (PDF - 82KB)
|
03/26/01
|
|
100
|
VICH GL18 Residual Solvents in New Veterinary Medicinal Products (PDF - 164KB)
|
11/02/11
|
|
102
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CVM GFI #102 Manufacture and Distribution of Unapproved Piperazine Products
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08/27/99
|
|
103
|
GFI #103 - Possible Dioxin/PCB Contamination of Drug and Biological Products
|
|
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104
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CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission (PDF - 174KB)
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07/10/01
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|
105
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GFI #105 - Computerized Systems Used in Clinical Investigations
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|
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106
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CVM GFI #106 Published Literature in Support of New Animal Drug Approval (PDF - 41KB)
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08/31/00
|
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108
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CVM GFI #108 How to Register with the CVM Electronic Submission System (PDF - 195KB)
|
09/30/11
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109
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VICH GL15 - Specific Recommendations for Equine (PDF - 119KB)
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06/27/02
|
|
110
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VICH GL16 - Specific Recommendations for Porcine (PDF - 118KB)
|
06/27/02
|
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111
|
VICH GL19- Specific Recommendations for Canine (PDF - 130KB)
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06/27/02
|
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112
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GFI #112 - Fumonisin Levels in Human Foods and Animal Feeds; Final Guidance
|
|
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113
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VICH GL20 - Specific Recommendations for Feline (PDF - 128KB)
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06/19/02
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114
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VICH GL21 - Specific Recommendations for Poultry-Gallus Gallus (PDF - 121KB)
|
06/19/02
|
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115
|
VICH GL22 -Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies (PDF - 74KB)
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07/27/06
|
|
116
|
VICH GL23 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (PDF - 73KB)
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07/27/06
|
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117
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VICH GL24 - Management of Adverse Event Reports (AER's) (PDF - 121KB)
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05/01/06
|
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118
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CVM GFI #118 Mass Spectrometry for Confirmation of Identity of Animal Drug Resides (PDF - 112KB)
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05/01/03
|
|
119
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CVM GFI #119 How CVM Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug (PDF - 33KB)
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08/29/02
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|
120
|
CVM GFI #120 Veterinary Feed Directive Regulation (PDF - 78KB)
|
03/26/09
|
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122
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CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores (PDF - 94KB)
|
11/09/04
|
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123
|
CVM GFI #123 Development of Data Supporting Approval of NSAIDS for Use in Animal (PDF - 52KB)
|
01/05/06
|
|
126
|
CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation (PDF - 134KB)
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06/01/06
|
|
132
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CVM GFI #132 The Administrative New Animal Drug Application Process (PDF - 51KB)
|
11/06/02
|
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135
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CVM GFI #135 Validation of Analytical Procedures for Type C Medicated Feeds (PDF - 107KB)
|
11/07/05
|
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136
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CVM GFI #136 Method Transfer Studies for Type C Medicated Feed Assay Methods (PDF - 105KB)
|
04/26/07
|
|
137
|
CVM GFI #137 Analytical Methods Description for Type C Medicated Feeds (PDF - 94KB)
|
05/08/07
|
|
141
|
VICH GL28 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing, (PDF - 60KB)
|
07/27/06
|
|
142
|
VICH GL29 - Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) (PDF - 94KB)
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12/12/01
|
|
143
|
VICH GL30 - Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms (PDF - 68KB)
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06/20/07
|
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144
|
VICH GL27 - Pre-Approval for Registration of New VMPs for Food-Producing Animals to Antimicrobial Resistance (PDF - 109KB)
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04/27/04
|
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145
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GFI #145 -Bioanalytical Method Validation
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|
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147
|
VICH GL31 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food Repeat Dose (90 Day) Toxicity Testing (PDF - 166KB)
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11/12/03
|
|
148
|
VICH GL32 - Developmental Toxicity Testing (PDF - 52KB)
|
07/27/06
|
|
149
|
VICH GL33 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing (PDF - 102KB)
|
03/17/09
|
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150
|
CVM GFI #150 Concerns Related to the use of Clove Oil as an Anesthetic for Fish (PDF - 41KB)
|
04/24/07
|
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152
|
CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern (PDF - 290KB)
|
10/23/03
|
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153
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CVM GFI #153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88KB)
|
09/01/02
|
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156
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CVM GFI #156 Comparability Protocols-Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
|
02/01/03
|
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158
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CVM GFI #158 Use of Material from Deer and Elk in Animal Feed (PDF - 43KB)
|
09/15/03
|
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159
|
VICH GL36 - Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (PDF - 293KB)
|
06/02/11
|
|
160
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VICH GL37 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing (PDF - 75KB)
|
07/27/06
|
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166
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VICH GL38 - EIA's for Veterinary Medicinal Products, Phase II (PDF - 427KB)
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01/09/06
|
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169
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CVM GFI #169 Drug Substance: Chemistry, Manufacturing, and Controls Information (PDF - 363KB)
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08/06/10
|
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170
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CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions (PDF - 140KB)
|
10/01/08
|
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171
|
CVM GFI #171 Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles (PDF - 107KB)
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10/06/08
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173
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CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA) (PDF - 52KB)
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02/07/05
|
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173
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CVM GFI #173 Appendix for the Animal Drug Sponsor Fees Under the (ADUFA) (PDF - 44KB)
|
02/07/05
|
|
176
|
VICH GL39 - Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances (PDF - 277KB)
|
06/14/06
|
|
177
|
VICH GL40 - Test Procedures/Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Product (PDF - 192KB)
|
06/14/06
|
|
178
|
CVM GFI #178 Design/Evaluation of Effectiveness Studies - Swine Respiratory Disease Claims (PDF - 140KB)
|
10/01/07
|
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179
|
CVM GFI #179 Use of Animal Clones and Clone Progeny for Human Food/Animal Feed (PDF - 52KB)
|
01/15/08
|
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181
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CVM GFI #181 Blue Bird Medicated Feed Labels (PDF - 60KB)
|
04/10/08
|
|
182
|
VICH GL42 - Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports (PDF - 167KB)
|
05/01/06
|
|
183
|
CVM GFI #183 ADUFA- Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction (PDF - 117KB)
|
03/09/07
|
|
185
|
VICH GL43 - Target Animal Safety for Veterinary Pharmaceutical Products (PDF - 261KB)
|
04/24/09
|
|
187
|
CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (PDF - 149KB)
|
01/15/09
|
|
188
|
CVM GFI #188 Draft Guidance for Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine (PDF - 167KB)
|
05/24/10
|
|
191
|
CVM GFI #191 New NADAs vs. Category II Supplemental NADAs (PDF - 161KB)
|
11/19/09
|
|
192
|
CVM GFI #192 Anesthetics for Companion Animals (PDF - 177KB)
|
03/25/10
|
|
195
|
CVM GFI #195 Small Entities Compliance Guide For Renderers—Substances Prohibited From Use In Animal Food Or Feed (PDF - 251KB)
|
05/06/09
|
|
197
|
CVM GFI #197 Documenting Statistical Analysis Programs and Data Files (PDF - 47KB)
|
05/04/10
|
|
198
|
VICH GL45 - Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products (PDF - 168KB)
|
07/21/09
|
|
199
|
CVM GFI #199 - Animal Generic Drug User Fees and Fee Waivers and Reductions (PDF - 87KB)
|
05/13/09
|
|
200
|
CVM GFI #200 - Small Entities Compliance Guide Designation of New Animal Drugs for Minor Uses/Minor Species (PDF - 53KB)
|
09/01/10
|
|
201
|
CVM GFI #201 - SECG for Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (PDF - 59KB)
|
09/01/10
|
|
204
|
CVM GFI #204 Active Controls in Studies to Demonstrate Effectiveness of a NAD for use in Companion Animals (PDF - 188KB)
|
06/20/12
|
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205
|
VICH GL46 - Metabolism Study to Determine the Quantity and Identify the Nature of Residues (PDF - 141KB)
|
09/15/11
|
|
206
|
VICH GL47 - Comparative Metabolism Studies In Laboratory Animals (PDF - 105KB)
|
09/15/11
|
|
207
|
VICH GL48 - Marker Residue Depletion Studies to Establish Product Withdrawal Periods (PDF - 190KB)
|
09/15/11
|
|
208
|
VICH GL49 - Validation of Analytical Methods Used in Residue Depletion Studies (PDF - 244KB)
|
09/15/11
|
|
|
Guidance for Industry: Sanitary Transportation of Food
|
04/30/10
|
|
|
Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)
|
05/24/10
|
|
209
|
CVM GFI#209 The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (PDF - 251KB)
|
04/13/12
|
|
|
FDA's Strategy on Antimicrobial Resistance - Questions and Answers
|
06/28/10
|
|
|
Guidance for Industry and FDA: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal Feed
|
06/29/10
|
|
211
|
CVM GFI #211 Residual Solvents Q (PDF - 79KB)
|
12/02/10
|
|
214
|
VICH GL35 - Electronic Standards for Transfer of Data (PDF - 306KB)
|
09/14/11
|
|
215
|
CVM GFI #215 Target Animal Safety and Effectiveness Protocol Development and Submission (PDF - 63KB)
|
09/29/11
|
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216
|
CVM GFI #216 - CMC Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use (PDF - 78KB)
|
03/08/12
|
|
217
|
CVM GFI #217 Effectiveness of Anticoccidial Drugs in Food-Producing Animals (PDF - 294KB)
|
11/22/11
|
|
|
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA (PDF - 66KB)
|
01/11/06
|
|
|
Providing Regulatory Submissions in Electronic Format--General Considerations
|
10/22/03
|
|
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CVM GFI #196 Process Validation: General Principles and Practices (PDF - 292KB)
|
01/24/11
|
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213
|
CVM GFI #213 - New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (PDF - 179KB)
|
04/13/12
|
|
219
|
VICH GL51 - Statistical Evaluation of Stability Data (PDF - 97KB)
|
04/04/12
|
|
|
CFSAN/CVM -Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories
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