| No. |
Title |
Date |
| 3. |
General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals |
07/27/06 |
| 5. |
Stability Guidelines |
12/90 |
| 6. |
Guidelines for Submitting NADA's for Generic Drugs Reviewed by NAS/NRC |
03/19/76 |
| 10. |
Amendment of Section II(G)(1)(b)(4) of the Preclearance Guidelines |
10/75 |
| 13. |
Guidelines for Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds revision of Medicated Block |
01/85 |
| 22. |
Guideline Labeling of Arecoline Base Drugs Intended for Animal Use |
|
| 23. |
Medicated Free Choice Feeds--Manufacturing Control |
07/85 |
| 24. |
Guidelines for Drug Combinations for Use in Animals |
10/83 |
| 35. |
Bioequivalence Guidance |
11/08/06 |
| 37. |
Guidelines for Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for Pigmentation |
03/84 |
| 38. |
Guideline for Effectiveness Evaluation of Topical/Otic Animal Drugs |
03/84 |
| 40. |
Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in Poultry |
04/92 |
| 42. |
Series of four guidelines entitled "Animal Drug Manufacturing Guidelines" |
1994 |
| 45. |
Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle |
08/93 |
| 48. |
Guidance for Industry: Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products |
11/94 |
| 49. |
Guidance Document For Target Animal Safety And Drug Effectiveness Studies For Anti-Microbial Bovine Mastitis Products (Lactating and Non-Lactating Cow Products) |
04/96 |
| 50. |
Draft Guideline for Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products |
02/93 |
| 53. |
Guideline for the Evaluation of the Utility of Food Additives in Diets Fed to Aquatic Animals |
05/94 |
| 55. |
Supportive Data for Cat Food Labels Bearing "Reduces Urinary pH Claims: Guideline in Protocol Development |
06/94 |
| 56. |
Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials |
07/10/01 |
| 57. |
Master Files: Guidance for Industry for the Preparation and Submission of Veterinary Master Files |
1995 |
| 59. |
Guidance for Industry: How to Submit a Notice of Claimed Investigational Exemption in Electronic Format to CVM |
06/15/09 |
| 61. |
Guidance For Industry: FDA Approval of New Animal Drugs for Minor Uses and for Minor Species |
5/29/08 |
| 62. |
Guidance for Industry: Consumer-Directed Broadcast Advertisements: Final Guidance |
08/99 |
| 63. |
Guidance for Industry: Validation of Analytical Procedures: Definition and Terminology |
07/99 |
| 64. |
Guidance for Industry: Validation of Analytical Procedures: Methodology: Final Guidance |
07/99 |
| 65. |
Guidance for Industry: Industry-Supported Scientific and Educational Activities |
11/97 |
| 67. |
Guidance for Industry: Small Entities Compliance Guide for Renderers |
02/98 |
| 68. |
Guidance for Industry: Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors |
02/98 |
| 69. |
Guidance for Industry: Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations |
02/98 |
| 70. |
Guidance for Industry: Small Entities Compliance Guide for Feeders of Ruminant Animals without On-Farm Feed Mixing Operations |
07/13/09 |
| 72. |
Guidance For Industry: GMP'S For Medicated Feed Manufacturers Not Required to Register and be Licensed with FDA |
05/98 |
| 73. |
Guidance For industry: Stability Testing Of New Veterinary Drug Substances And Medicinal Products VICH GL3(R): Revised Guidance |
11/21/07 |
| 74. |
Guidance for Industry: Stability Testing of New Veterinary Dosage Forms VICH GL4: FINAL GUIDANCE |
09/99 |
| 75. |
Guidance For Industry: Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products: Final GUIDANCE |
09/99 |
| 76. |
Guidance For Industry: Questions and Answers BSE Feed Regulations |
07/98 |
| 79. |
Guidance for Industry #79 - Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (CVM) - Final Guidance |
07/05 |
| 80. |
Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds |
11/21/02 |
| 82. |
Guidance for Industry: Development of Supplemental Applications for Approved New Animal Drugs - Final Guidance |
10/28/02 |
| 83. |
Guidance for Industry: Chemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA: FINAL GUIDANCE |
05/30/07 |
| 84. |
Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling: DRAFT GUIDANCE |
03/99 |
| 85. |
Guidance for Industry: Good Clinical Practices: VICH GL9, Final Guidance |
05/09/01 |
| 86. |
Guidance for Industry - How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format to CVM |
06/15/09 |
| 87. |
Guidance for Industry - How to Submit a Notice of Intent to Slaughter for Human Food Purposes in Electronic Format to CVM |
06/15/09 |
| 88. |
Guidance for Industry - How to Submit a Request for a Meeting or Teleconference in Electronic Format to CVM |
06/15/09 |
| 89. |
Guidance for Industry - Environmental Impact Assessments (EIA's) For Veterinary Medicinal Products (VMP's) - Phase I, VICH GL6: Final Guidance |
03/07/01 |
| 90. |
Guidance for Industry - Effectiveness of Anthelmintics: General Recommendations, Final Guidance - VICH GL7 (replaces 3/26/2001) |
10/11/01 |
| 91. |
Guidance for Industry: International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal products (VICH); Final Guidance on Stability Testing for Medicated Premixes (VICH GL8); Availability |
03/00 |
| 92. |
Guidance for Industry #92: Impurities In New Veterinary Drug Substances (Revision), VICH GL10 ( R) , Revised Guidance |
11/21/07 |
| 93. |
Guidance for Industry #93 - Impurities in New Veterinary Medicinal Products (Revised), Revised Guidance - VICH GL11 (R), |
11/21/07 |
| 95. |
Guidance for Industry: Efficacy Of Anthelmintics: Specific Recommendations for Bovines: VICH GL12, Final Guidance |
03/26/01 |
| 96. |
Guidance for Industry: Efficacy Of Anthelmintics: Specific Recommendations for Ovines: VICH GL13, Final Guidance |
03/26/01 |
| 97. |
Guidance for Industry: Efficacy Of Anthelmintics: Specific Recommendations for Caprines: VICH GL14, Final Guidance |
03/26/01 |
| 98. |
Dioxin In Anti-Caking Agents Used In Animal Feed And Feed Ingredients |
04/12/00 |
| 99. |
Guidance for Industry: Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products - VICH GL17- Final Guidance |
03/26/01 |
| 100. |
Guidance for Industry: Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients: VICH GL18, Final Guidance |
05/15/01 |
| 102. |
Guidance for Industry: Manufacture and Distribution of Unapproved Piperazine Products |
08/99 |
| 103. |
Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products |
08/99 |
| 104. |
Guidance for Industry: Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission to the Division of Therapeutic Drugs for Non-Food Animals |
07/10/01 |
| 105. |
Guidance for Industry: Computerized Systems Used in Clinical Investigations |
05/07 |
| 106. |
The Use of Published Literature in Support of New Animal Drug Approval |
08/31/00 |
| 107. |
Guidance for Industry: How to Submit a Protocol without Data in Electronic Format to CVM |
06/15/09 |
| 108. |
Guidance for Industry: How to Submit Information in Electronic Format to CVM using the FDA Electronic Submission Gateway |
06/15/09 |
| 109. |
Guidance for Industry #109: Effectiveness of Anthelmintics: Specific Recommendations for Equine - VICH GL15 - Final Guidance |
06/27/02 |
| 110. |
Guidance for Industry #110: Effectiveness of Anthelmintics: Specific Recommendations for Porcine - VICH GL16 - Final Guidance |
06/27/02 |
| 111. |
Guidance for Industry #111: Effectiveness of Anthelmintics: Specific Recommendations for Canine - VICH GL19 - Final Guidance |
06/27/02 |
| 112. |
Guidance For Industry #112 : Fumonisin Levels in Human Foods and Animal Feeds - Final Guidance |
11/09/01 |
| 113. |
Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Feline - VICH GL20 - Final Guidance |
06/19/02 |
| 114. |
Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Poultry-Gallus Gallus - VICH GL21 - Final Guidance |
06/19/02 |
| 115. |
Guidance for Industry: Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies - VICH GL22 - Final Guidance |
07/27/06 |
| 116. |
Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing - VICH GL23 - Final Guidance |
07/27/06 |
| 117. |
Guidance for Industry: Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AER's) - VICH GL24 - DRAFT GUIDANCE |
05/02/06 |
| 118. |
Guidance for Industry: Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues - Final Guidance |
05/01/03 |
| 119. |
Guidance for Industry and Reviewers: How the Center for Veterinary Medicine Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug - Final Guidance |
08/29/02 |
| 120. |
Guidance for Industry #120: Veterinary Feed Directive Regulation |
03/26/09 |
| 121. |
Guidance for Industry #121: Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims |
03/06/01 |
| 122. |
Guidance for Industry: Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores, May 18, 2004 |
11/09/04 |
| 123. |
Guidance for Industry: Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for Use in Animals, Final, January 5, 2006 |
01/05/06 |
| 124. |
Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering - Draft |
01/17/01 |
| 126. |
Guidance for Industry: BACPAC I: Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation,-June 1, 2006 |
06/01/06 |
| 132. |
Guidance for Industry: The Administrative New Animal Drug Application Process - Draft |
11/06/02 |
| 135. |
Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds, Final |
11/07/05 |
| 136. |
Guidance for Industry #136 -Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods- Final Guidance |
04/26/07 |
| 137. |
Guidance for Industry - Analytical Methods Description for Type C Medicated Feeds, Final |
05/08/07 |
| 141. |
Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing, VICH GL28, Final Guidance |
07/27/06 |
| 142. |
CVM Guidance for Industry #142: Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) - VICH GL29 - Draft Guidance |
12/12/01 |
| 143. |
CVM Guidance for Industry: Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms - VICH GL30 - Revised Draft Guidance |
06/20/07 |
| 144. |
Guidance for Industry: Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial Resistance - VICH GL27, Final Guidance |
04/27/04 |
| 145. |
Bioanalytical Method Validation |
05/01 |
| 147. |
Guidance for Industry 147: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity Testing - VICH GL31 |
07/27/06 |
| 148. |
Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing - VICH GL32 Final Guidance |
07/27/06 |
| 149. |
Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing VICH GL33 |
03/17/09 |
| 150. |
Guidance for Industry: Concerns Related to the use of Clove Oil as an Anesthetic for Fish |
04/24/07 |
| 151. |
Guidance for Industry: FDA Export Certificates |
07/04 |
| 152. |
Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern |
10/23/03 |
| 153. |
Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals |
09/02 |
| 156. |
Draft Guidance for Industry: Comparability Protocols--Chemistry, Manufacturing, and Controls Information; Availability |
02/03 |
| 157. |
Guidance for Industry: Part 11, Electronic Records, Electronic Signatures--Scope and Application |
08/03 |
| 158. |
Guidance for Industry - Use of Material from Deer and Elk in Animal Feed |
09/15/03 |
| 159. |
Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI - VICH GL-36, Final Guidance |
08/30/06 |
| 160. |
Guidance for Industry - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing, Final Guidance, VICH GL-37 |
07/27/06 |
| 162. |
Draft Guidance for Industry - Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information |
09/03 |
| 163. |
Draft Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP |
08/03 |
| 164. |
Guidance for Industry - PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, September 2004 |
09/04 |
| 165. |
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations |
10/03 |
| 166. |
Guidance for Industry - Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMPs), Phase II, Final Guidance, VICH GL38 |
01/09/06 |
| 167. |
Guidance for Industry: Prior Notice of Imported Food Questions and Answers |
12/12/03 |
| 168. |
Guidance to Industry: Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators |
11/20/03 |
| 169. |
Guidance for Industry: Drug Substance: Chemistry, Manufacturing, and Controls Information, Draft Guidance |
06/01/06 |
| 170. |
Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions, Final Guidance |
09/04/08 |
| 171. |
Guidance for Industry: Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles |
10/6/08 |
| 173. |
Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
Appendix | pdf |
02/07/05 |
| 174. |
Guidance for Industry - Use of Material from BSE Positive Cattle in Animal Feed |
09/30/04 |
| 176. |
Guidance for Industry - Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances - VICH GL-39 |
06/14/06 |
| 177. |
Guidance for Industry - Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products - VICH GL-40 |
06/14/06 |
| 178. |
Guidance for Industry - Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims |
10/02/07 |
| 179. |
Draft Guidance for Industry Use of Edible Products from Animal Clones or their Progeny for Human Food or Animal Feed |
12/28/06 |
| 179. |
Guidance for Industry Use of Animal Clones and Clone Progeny for Human Food and Animal Feed |
01/15/08 |
| 181. |
Guidance for Industry--Blue Bird Medicated Feed Labels |
04/10/08 |
| 182. |
Guidance for Industry - Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports-VICH GL42- Draft Guidance |
05/02/06 |
| 183. |
Guidance for Industry- Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction |
03/09/07 |
| 185. |
Guidance for Industry -Target Animal Safety for Veterinary Pharmaceutical Products VICH GL43 |
04/24/09 |
| 187. |
Draft Guidance for Industry - Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs |
09/18/08 |
| 187. |
Guidance for Industry - Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs |
01/15/09 |
| 190. |
Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products |
02/25/08 |
| 191. |
Guidance for Industry Changes to Approved NADAs —New NADAs vs. Category II Supplemental NADAs |
11/19/09 |
| 192. |
Draft Guidance for Industry: Anesthetics for Companion Animals |
12/17/08 |
| 193. |
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format -- Drug Establishment Registration and Drug Listing |
07/10/08 |
| 194. |
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes |
08/4/08 |
| 195. |
Small Entities Compliance Guide For Renderers—Substances Prohibited From Use In Animal Food Or Feed |
05/06/09 |
| 196. |
Process Validation: General Principles and Practices |
11/18/08 |
| 197. |
Draft Guidance for Industry - Documenting Statistical Analysis Programs and Data Files |
04/27/09 |
| 198. |
Draft Guidance for Industry - VICH GL45 - Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products |
07/21/09 |
| 199. |
Guidance for Industry - Animal Generic Drug User Fees and Fee Waivers and Reductions |
05/13/09 |
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