Animal & Veterinary

Guidance by Number

CVM Guidances
Cross-Cutting Guidances

     

Guidance by Number

No.TitleDate
3 CVM GFI #3 General Principles for Evaluating the Safety of Compounds Used in Food Producing Animals (PDF - 223KB) 07/25/06
5 CVM GFI #5 Stability Guidelines (PDF - 385KB) 12/09/08
6 CVM GFI #6 Submitting NADA's for Generic Drugs Reviewed by NAS/NR 03/19/76
13 CVM GFI #13 Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds-Medicated Block 01/01/85
23 CVM GFI #23 Medicated Free Choice Feeds--Manufacturing Control 07/01/85
24 CVM GFI #24 Drug Combinations for Use in Animals 10/01/83
35 CVM GFI #35 Bioequivalence Guidance (PDF - 182KB) 11/08/06
37 CVM GFI #37 Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for Pigmentation 03/01/84
38 CVM GFI #38 Guideline for Effectiveness Evaluation of Topical/Otic Animal Drugs 08/21/84
42 CVM GFI #42 Animal Drug Manufacturing Guidelines- Series of Four Guidelines 01/01/94
45 CVM GFI #45 Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle 08/01/93
49 CVM GFI #49 Target Animal Safety And Drug Effectiveness Studies for Anti-Microbial Bovine Mastitis Products (Lactating and Non-Lactating Cow Products) 04/04/96
50 CVM GFI #50 Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products 02/01/93
53 CVM GFI #53 Evaluation of the Utility of Food Additives in Diet Fed to Aquatic Animals 05/01/94
55 CVM GFI #55 Supportive Data for Cat Food Labels Bearing "Reduces Urinary pH Claims: Protocol Development 06/01/94
56 CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials (PDF - 60KB) 07/10/01
57 CVM GFI #57 Preparation and Submission of Veterinary Master Files (PDF - 110KB) 01/01/95
61 CVM GFI #61 FDA Approval of New Animal Drugs for MUMS (PDF - 507KB) 05/29/08
CVM GFI #62 Consumer Directed Broadcast Advertisements 08/01/99
63 VICH GL1 - Validation of Analytical Procedures: Definition and Terminology (PDF - 118KB) 07/01/99
64 VICH GL2 - Validation of Analytical Procedures: Methodology: Final Guidance (PDF - 218KB) 07/01/99
CVM GFI #65 Industry Supported Scientific and Educational Activities (PDF - 428KB) 11/01/97
67 CVM GFI #67 Small Entities Compliance Guide for Renderers (PDF - 66KB) 02/01/98
68 CVM GFI #68 Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors (PDF - 66KB) 02/01/98
69 CVM GFI #69 Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations (PDF - 62KB) 02/01/98
70 CVM GFI #70 Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations (PDF - 59KB) 07/13/09
72 CVM GFI #72 GMP'S For Medicated Feed Manufacturers Not Required to Register and be Licensed with FDA (PDF - 57KB) 05/01/98
73 VICH GL3(R) - Stability Testing Of New Veterinary Drug Substances (PDF - 228KB) 11/21/07
74 VICH GL4 - Stability Testing of New Veterinary Dosage Forms (PDF - 79KB) 09/01/99
75 VICH GL5 -Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products (PDF - 76KB) 09/01/99
76 CVM GFI #76 Questions and Answers BSE Feed Regulations (PDF - 152KB) 07/01/98
79 CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM (PDF - 139KB) 05/29/14
80 CVM GFI #80 Evaluation the Utility of Anti-Salmonella Chemical Food Additives (PDF - 78KB) 11/21/02
82 CVM GFI #82 Development of Supplemental Applications for Approved New Animal Drugs (PDF - 238KB) 10/28/02
83 CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA (PDF - 162KB) 05/30/07
85 VICH GL9 - Good Clinical Practice (PDF - 356KB) 05/09/01
89 VICH GL6 - EIA's for Veterinary Medicinal Products - Phase I (PDF - 106KB) 03/07/01
90 VICH GL7 - Effectiveness of Anthelmintics: General Recommendations (PDF - 98KB) 10/11/01
91 VICH GL8 - Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products on Stability Testing for Medicated Premixes (PDF - 47KB) 03/01/00
92 VICH GL10(R) - Impurities In New Veterinary Drug Substances (PDF - 150KB) 11/26/07
93 VICH GL11(R) - Impurities in New Veterinary Medicinal Products (PDF - 134KB) 11/21/07
95 VICH GL12 - Efficacy of Anthelmintics: Specific Recommendations for Bovines (PDF - 96KB) 03/26/01
96 VICH GL13 - Efficacy of Anthelmintics: Specific Recommendations for Ovines (PDF - 86KB) 03/26/01
97 VICH GL14 - Efficacy of Anthelmintics: Specific Recommendations for Caprines (PDF - 90KB) 03/26/01
98 CVM GFI #98 Dioxin In Anti-Caking Agents In Animal Feed And Feed Ingredients (PDF - 35KB) 04/12/00
99 VICH GL17 - Testing of New Biotechnological/Biological Products (PDF - 118KB) 03/26/01
100 VICH GL18 Residual Solvents in New Veterinary Medicinal Products (PDF - 164KB) 11/02/11
102 CVM GFI #102 Manufacture and Distribution of Unapproved Piperazine Products 08/27/99
103 GFI #103 - Possible Dioxin/PCB Contamination of Drug and Biological Products
104 CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission (PDF - 174KB) 07/10/01
105 GFI #105 - Computerized Systems Used in Clinical Investigations
106 CVM GFI #106 Published Literature in Support of New Animal Drug Approval (PDF - 41KB) 08/31/00
108 CVM GFI #108 How to Register with the CVM Electronic Submission System (PDF - 433KB) 06/09/15
109 VICH GL15 - Specific Recommendations for Equine (PDF - 199KB) 06/27/02
110 VICH GL16 - Specific Recommendations for Porcine (PDF - 196KB) 06/27/02
111 VICH GL19- Specific Recommendations for Canine (PDF - 214KB) 06/27/02
GFI #112 - Fumonisin Levels in Human Foods and Animal Feeds; Final Guidance 11/09/01
113 VICH GL20 - Specific Recommendations for Feline (PDF - 227KB) 06/19/02
114 VICH GL21 - Specific Recommendations for Poultry-Gallus Gallus (PDF - 201KB) 06/19/02
115 VICH GL22 -Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies (PDF - 104KB) 07/27/06
116 VICH GL23 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (PDF - 222KB) 05/13/15
117 VICH GL24 - Management of Adverse Event Reports (AER's) (PDF - 121KB) 05/01/06
118 CVM GFI #118 Mass Spectrometry for Confirmation of Identity of Animal Drug Resides (PDF - 112KB) 05/01/03
119 CVM GFI #119 How CVM Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug (PDF - 33KB) 08/29/02
120 CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers (PDF - 183KB) 06/03/15
122 CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores (PDF - 94KB) 11/09/04
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) 06/01/06
132 CVM GFI #132 Administrative Applications and the Phased Review Process (PDF - 104KB) 05/06/15
135 CVM GFI #135 Validation of Analytical Procedures for Type C Medicated Feeds (PDF - 107KB) 11/07/05
136 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 - 83KB) 07/27/06
142 VICH GL29 - Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) (PDF - 152KB) 12/06/01
143 VICH GL30 - Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms (PDF - 149KB) 10/09/14
144 VICH GL27 - Pre-Approval for Registration of New VMPs for Food-Producing Animals to Antimicrobial Resistance (PDF - 180KB) 04/27/04
145 GFI #145 -Bioanalytical Method Validation
147 VICH GL31 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food Repeat Dose (90 Day) Toxicity Testing (PDF - 102KB) 07/27/06
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 - 171KB) 03/17/09
150 CVM GFI #150 Concerns Related to the use of Clove Oil as an Anesthetic for Fish (PDF - 41KB) 04/24/07
GFI #151 - FDA Export Certificates 07/12/04
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
156 CVM GFI #156 Comparability Protocols-Chemistry, Manufacturing, and Controls Information (PDF - 240KB) 02/01/03
158 CVM GFI #158 Use of Material from Deer and Elk in Animal Feed (PDF - 43KB) 09/15/03
159 VICH GL36 - Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (PDF - 533KB) 03/05/13
160 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
166 VICH GL38 - EIA's for Veterinary Medicinal Products, Phase II (PDF - 427KB) 01/09/06
169 CVM GFI #169 Drug Substance: Chemistry, Manufacturing, and Controls Information (PDF - 363KB) 08/06/10
170 CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions (PDF - 140KB) 10/01/08
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) 10/06/08
173 CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA) (PDF - 52KB) 02/07/05
173 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 - 286KB) 06/14/06
178 CVM GFI #178 Design/Evaluation of Effectiveness Studies - Swine Respiratory Disease Claims (PDF - 140KB) 10/01/07
179 CVM GFI #179 Use of Animal Clones and Clone Progeny for Human Food/Animal Feed (PDF - 52KB) 01/15/08
181 CVM GFI #181 Blue Bird Medicated Feed Labels (PDF - 60KB) 04/10/08
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 - 395KB) 04/24/09
187 CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (PDF - 134KB) 06/18/15
188 CVM GFI #188 Guidance for Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine (PDF - 255KB) 10/09/14
191 CVM GFI #191 New NADAs vs. Category II Supplemental NADAs (PDF - 183KB) 05/07/15
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
CVM GFI #196 Process Validation: General Principles and Practices (PDF - 372KB) 01/24/11
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 - 142KB) 07/31/15
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 - 71KB) 07/29/14
201 CVM GFI #201 - SECG for Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (PDF - 73KB) 07/29/14
203 CVM GFI #203 Ensuring Safety of Animal Feed Maintained and Fed On-Farm (PDF - 181KB) 03/20/15
204 CVM GFI #204 Active Controls in Studies to Demonstrate Effectiveness of a NAD for use in Companion Animals (PDF - 152KB) 10/24/13
205 VICH GL46 - Metabolism Study to Determine the Quantity and Identify the Nature of Residues (PDF - 210KB) 09/15/11
206 VICH GL47 - Comparative Metabolism Studies In Laboratory Animals (PDF - 138KB) 09/15/11
207 VICH GL48 - Marker Residue Depletion Studies to Establish Product Withdrawal Periods (PDF - 303KB) 03/09/15
208 VICH GL49 - Validation of Analytical Methods Used in Residue Depletion Studies (PDF - 291KB) 03/09/15
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 12/11/13
211 CVM GFI #211 Residual Solvents Q (PDF - 76KB) 04/03/15
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 - 115KB) 12/12/13
214 VICH GL35 - Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data (PDF - 1.5MB) 12/10/14
215 CVM GFI #215 Target Animal Safety and Effectiveness Protocol Development and Submission (PDF - 63KB) 09/29/11
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 - 181KB) 11/20/12
218 CVM GFI #218 - Cell-Based Products for Animal Use (PDF - 162KB) 06/12/15
219 VICH GL51 - Statistical Evaluation of Stability Data (PDF - 221KB) 05/13/14
220 GFI #220 - Use of Nanomaterials in Food for Animals (PDF - 63KB) 06/24/14
221 CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions (PDF - 122KB) 06/12/15
223 CVM GFI #223 Small Entity Compliance Guide Declaring Color Additives in Animal Foods (PDF - 48KB) 09/26/13
224 VICH GL52 - Bioequivalence: Blood Level Bioequivalence Study (PDF - 223KB) 09/24/14
224 Supplement to VICH GL52 - Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Draft Guidance GL52 (PDF - 131KB) 09/24/14
225 VICH GL53 - Electronic Exchange of Documents: File Format Recommendations (PDF - 157KB) 08/28/14
226 CVM GFI #226 - Target Animal Safety Data Presentation and Statistical Analysis (PDF - 449KB) 03/31/15
227 CVM GFI #227 - Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections (PDF - 70KB) 10/20/14
229 CVM GFI #229 - Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle - Draft (PDF - 212KB) 02/24/15
230 CVM GFI #230 - Compounding Animal Drugs from Bulk Drug Substances (PDF - 87KB) 05/19/15
232 CVM GFI #232 - VICH GL54 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD) (PDF - 145KB) 06/01/15

     

Cross-Cutting Guidances

Page Last Updated: 06/04/2015
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