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Table of Contents

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Published Guidance Documents

1-52 | 53 - 100 | 101 - 150 | 151 - 196


No.

Title

Date

3.

General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
| html | | pdf |
 

Revised 07/27/06

5.

Stability Guidelines | pdf |

Revised 12/9/08

6.

Guidelines for Submitting NADA's for Generic Drugs Reviewed by NAS/NRC

10/20/71;
rev. 03/19/76

13.

Guidelines for Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds revision of Medicated Block

01/85

16.

FOI Summary Guideline

05/85

21.

Nutritional Ingredients in Animal Drugs and Feeds Nutritional Ingredients in Animal Drugs and Feeds
(see Policy and Procedures Guide 1240.3420)

rev. 03/93

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

27.

New Animal Drug Determinations
(see Policy and Procedures Guide 1240.3500)

07/89

28.

Animal Drug Applications Expedited Review Guideline
(see Policy and Procedures Guide 1240.3135)

06/90

33.

Target Animal Safety Guidelines for New Animal Drugs

06/89

35.

Bioequivalence Guidance
| html | | pdf |
 

revised 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  -  html

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   -  html

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

54.

Draft Guideline for Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds  - See Final Guidance #80

06/94

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 | pdf |

07/10/2001

57.

Master Files: Guidance for Industry for the Preparation and Submission of Veterinary Master Files | pdf |

1995

59.

Guidance for Industry: How to Submit a Notice of Claimed Investigational Exemption in Electronic Format to CVM
| html | | pdf |
 

01/15/2008

61.

Guidance For Industry: FDA Approval of New Animal Drugs for Minor Uses and for Minor Species
| html | | pdf |
 

5/29/2008

62.

Guidance for Industry: Consumer-Directed Broadcast Advertisements: Final Guidance
| html | | pdf |
 

08/99

63.

Guidance for Industry: Validation of Analytical Procedures: Definition and Terminology
| html | | pdf |
 

07/99

64.

Guidance for Industry: Validation of Analytical Procedures: Methodology: Final Guidance
| html | | doc | | pdf |
 

07/99

65.

Guidance for Industry: Industry-Supported Scientific and Educational Activities
| pdf |
 

11/97

67.

Guidance for Industry: Small Entities Compliance Guide for Renderers
| html | | pdf |
 

02/98

68.

Guidance for Industry: Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors
| html | | pdf |
 

02/98

68.

Guía de la FDA para la Industria Número 68: Para Mezcladores de Proteínas, Fabricantes de Alimentos para Animales y Distribuidores
| doc | | pdf |
 

02/98

69.

Guía de la FDA para la Industria Número 69: Para Alimentadores de Animales Rumiantes con Operaciones de Mezclado de Alimentos en la Granja
| doc | | pdf |
 

02/98

69.

Guidance for Industry: Small Entities Compliance Guide for for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations
| html | | pdf |
 

02/98

70.

Guidance for Industry: Small Entities Compliance Guide for Feeders of Ruminant Animals without On-Farm Feed Mixing Operations
| html | | pdf |
 

02/98

70.

Guía de la FDA para la Industria Número70: Para Alimentadores de Animales Rumiantes sin Operaciones de Mezclado de Alimentos en la Granja
| doc | | pdf |
 

02/98

71.

Guidance for Industry: Use of Human Chorionic Gonadotropin (HCG) as a Spawning Aid for Fish

Rescinded

72.

Guidance For Industry: GMP'S For Medicated Feed Manufacturers Not Required to Register and be Licensed with FDA | pdf |

05/98

73.

Guidance For industry: Stability Testing Of New Veterinary Drug Substances And Medicinal Products VICH GL3(R): Revised Guidance
| html | | pdf | | FR Notice |
 

11/21/2007

74.

Guidance for Industry: Stability Testing of New Veterinary Dosage Forms VICH GL4: FINAL GUIDANCE
| html | | doc | | pdf |
 

09/99

75.

Guidance For Industry: Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products: Final GUIDANCE
| html | | doc | | pdf |
 

09/99

76.

Guidance For Industry: Questions and Answers BSE Feed Regulations | pdf |

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
| html | | doc | | pdf |
 

July 2005

80.

Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds
| html | | doc | | pdf |
 

11/21/2002

82.

Guidance for Industry: Development of Supplemental Applications for Approved New Animal Drugs - Final Guidance
| html | | doc | | pdf |
 

10/28/02

83.

Guidance for Industry: Chemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA: FINAL GUIDANCE
| html | | pdf | | FR Notice |
 

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
| html | | doc | | pdf |
 

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
| html | | pdf |
 

01/15/2008

87.

Guidance for Industry - How to Submit a Notice of Intent to Slaughter for Human Food Purposes in Electronic Format to CVM
| html | | pdf |
 

01/15/2008

88.

Guidance for Industry - How to Submit a Request for a Meeting or Teleconference in Electronic Format to CVM
| html | | pdf | | FR Notice |
 

01/15/2008

89.

Guidance for Industry - Environmental Impact Assessments (EIA's) For Veterinary Medicinal Products (VMP's) - Phase I, VICH GL6: Final Guidance
| html | | doc | | pdf |
 

03/07/2001

90.

Guidance for Industry - Effectiveness of Anthelmintics: General Recommendations, Final Guidance - VICH GL7 (replaces 3/26/2001)
| html | | doc | | pdf |
 

10/11/2001

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
| html | | doc | | pdf |
 

03/00

92.

Guidance for Industry #92: Impurities In New Veterinary Drug Substances (Revision), VICH GL10 ( R) , Revised Guidance
| html | | pdf | FR Notice
 

11/21/2007

93.

Guidance for Industry #93 - Impurities in New Veterinary Medicinal Products (Revised), Revised Guidance - VICH GL11 (R),
| html | | pdf | FR Notice
 

11/21/2007

95.

Guidance for Industry: Efficacy Of Anthelmintics: Specific Recommendations for Bovines: VICH GL12, Final Guidance
| html | | doc | | pdf |
 

03/26/2001

96.

Guidance for Industry: Efficacy Of Anthelmintics: Specific Recommendations for Ovines: VICH GL13, Final Guidance
| html | | doc | | pdf |
 

03/26/2001

97.

Guidance for Industry: Efficacy Of Anthelmintics: Specific Recommendations for Caprines: VICH GL14, Final Guidance
| html | | doc | | pdf |
 

03/26/2001

98.

Dioxin In Anti-Caking Agents Used In Animal Feed And Feed Ingredients
| html | | pdf |
 

Revised 04/12/00

99.

Guidance for Industry: Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products - VICH GL17- Final Guidance
| html | | doc | | pdf |
 

03/26/2001

100.

Guidance for Industry: Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients: VICH GL18, Final Guidance
| html | | doc | | pdf |
 

05/15/01

102.

Guidance for Industry: "Manufacture and Distribution of Unapproved Piperazine Products" - Revised

08/99

103.

Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products
| pdf | text |
 

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
| html | | doc | | pdf |
 

07/10/01

105.

Draft Guidance for Industry: Computerized Systems Used in Clinical Trials, Revision 1, Erratum, September 2004 | htm | | pdf |

09/04

106.

The Use of Published Literature in Support of New Animal Drug Approval
| html | | wpd | | pdf |
 

08/31/00

107.

Guidance for Industry: How to Submit a Protocol without Data in Electronic Format to CVM
| html | | pdf |
 

01/15/2008

108.

Guidance for Industry: How to Submit Information in Electronic Format to CVM using the FDA Electronic Submission Gateway
| html | | pdf |
 

01/15/2008

109.

Guidance for Industry #109: Effectiveness of Anthelmintics: Specific Recommendations for Equine - VICH GL15 - Final Guidance
| html | | doc | | pdf |
 

06/27/02

110.

Guidance for Industry #110: Effectiveness of Anthelmintics: Specific Recommendations for Porcine - VICH GL16 - Final Guidance
| html | | doc | | pdf |
 

06/27/02

111.

Guidance for Industry #111: Effectiveness of Anthelmintics: Specific Recommendations for Canine - VICH GL19 - Final Guidance
| html | | doc | | pdf |
 

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
| html | | doc | | pdf |
 

06/19/02

114.

Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Poultry-Gallus Gallus - VICH GL21 - Final Guidance
| html | | doc | | pdf |
 

06/19/02

115.

Guía para la Industria 115 - Estudios para Evaluar la Seguridad de Residuos de Medicamentos Veterinarios en Alimentos Humanos: Estudios de Toxicidad Reproductiva - VICH GL22 - Guia Final
| html | | doc | | pdf |
 

07/27/2006

115.

Guidance for Industry: Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies - VICH GL22 - Final Guidance
| html | | pdf |
 

Revised 07/27/06

116.

Guía para la Industria 116 - Estudios para Evaluar la Seguridad de Residuos de Medicamentos Veterinarios en Alimentos Humanos: Estudios de Toxicidad Genética - VICH GL23 - Guia Final
| html | | doc | | pdf |
 

07/27/2006

116.

Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing - VICH GL23 - Final Guidance
| html | | pdf |
 

Revised 07/27/06

117.

Guidance for Industry: Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AER's) - VICH GL24 - DRAFT GUIDANCE
| html | | pdf | FR Notice
 

05/02/06

118.

Guidance for Industry: Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues - Final Guidance
| html | | doc | | pdf |
 

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
| html | | doc | | pdf |
 

08/29/02

120.

Guidance for Industry #120 - Veterinary Feed Directive Regulation
| html | | pdf |
 

Revised 06/26/07

121.

Guidance for Industry #121: Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims
| html | | doc | | pdf |
 

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
| html | | doc | | pdf |
 

Revised
11/09/04

123.

Guidance for Industry 123 - 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
| html | | doc | | pdf | FR Notice
 

01/05/06

124.

Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering - Draft
| html | | pdf |
 

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
| html | | pdf | | FR Notice |
 

Revised 06/01/06

132.

Guidance for Industry: The Administrative New Animal Drug Application Process - Draft
| html | | pdf |
 

11/06/02

135.

Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds, Final
| html | | pdf |
 

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
| html | | pdf | | FR Notice |
 

04/26/07

137.

Guidance for Industry - Analytical Methods Description for Type C Medicated Feeds, Final
| html | | pdf | | FR Notice |
 

05/08/07

141.

Guía para la Industria 141- Estudios para Evaluar la Seguridad de Residuos de Medicamentos Veterinarios en Alimentos Humanos: Estudios de Carcinogenicidad, Guia Final, VICH GL28, Julio 27, 2006
| html | | pdf |
 

07/27/06

141.

Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing, VICH GL28, Final Guidance
| html | | pdf |
 

Revised 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 | pdf |

12/12/01

143.

CVM Guidance for Industry #143: Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms - VICH GL30 - Revised Draft Guidance
| html | | pdf | FR Notice   
 

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
| html | | doc | | pdf |
 

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
| html | | pdf |
 

Revised 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
| html | | pdf |
 

Revised 07/27/06

148.

Estudios para Evaluar la Seguridad de Residuos de Medicamentos Veterinarios en Alimentos Humanos: Estudio de Toxicidad del Desarrollo - VICH GL32 - Guia Final
| html | | pdf |
 

07/27/2006

149.

Guía para la Industria 149 - Estudios para Evaluar la Seguridad de Residuos de Medicamentos Veterinarios en Alimentos para Humanos: Enfoque General de los Estudios - VICH GL33 - Guia Final
| html | | doc | | pdf |
 

07/27/2006

149.

Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing VICH GL33 html | pdf |

Revised 07/27/06

150.

Guidance for Industry: Concerns Related to the use of Clove Oil as an Anesthetic for Fish html | pdf |

Revised 4/24/07

151.

Guidance for Industry: FDA Export Certificates
| html | | pdf |
 

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 | doc | | pdf |

10/23/03

153.

Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals html | pdf |

09/02

156.

Draft Guidance for Industry: Comparability Protocols--Chemistry, Manufacturing, and Controls Information; Availability html | doc | | pdf |

02/03

157.

Guidance for Industry: Part 11, Electronic Records, Electronic Signatures--Scope and Application | doc | | pdf |

08/03

158.

Guidance for Industry - Use of Material from Deer and Elk in Animal Feed html | doc | | pdf |

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
| html | | pdf |
 

Revised 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
| html | | pdf |
 

Revised 07/27/2006

162.

Draft Guidance for Industry - Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information | pdf |

09/03

163.

Draft Guidance for Industry : Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP | doc | | pdf |

08/03

164.

Guidance for Industry - PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, September 2004 | htm | | pdf |

09/04

165.

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations | doc | | pdf |

10/03

166.

Guidance for Industry - Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMPs), Phase II, Final Guidance, VICH GL38,
| html | | pdf | FR Notice
 

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
| html | | pdf | | FR Notice |
 

Revised 06/01/06

170.

Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions, Final Guidance
| html | | pdf |
 

Revised 09/04/08

171.

Guidance for Industry on Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
| pdf |
 

Revised 10/6/08

173.

Guidance for Industry - Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
| doc | | pdf | Appendix | pdf | | doc |
 

02/07/05

174.

Guidance for Industry - Use of Material from BSE Positive Cattle in Animal Feed
| html | | doc | | pdf |
 

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
| html | | pdf | | FR Notice |
 

06/14/06

177.

Guidance for Industry - Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products - VICH GL-40
| html | | pdf | | FR Notice |
 

06/14/06

178.

Guidance for Industry - Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims
| html | | pdf | | FR Notice |
 

10/02/2007

179.

Guidance for Industry Use of Animal Clones and Clone Progeny for Human Food and Animal Feed
| html | | pdf |
 

01/15/2008

179.

Draft Guidance for Industry Use of Edible Products from Animal Clones or their Progeny for Human Food or Animal Feed
| html | | pdf | | FR Notice |
 

12/28/06

181.

Guidance for Industry--Blue Bird Medicated Feed Labels
| html | | pdf | | FR Notice |
 

4/10/08

182.

Guidance for Industry - Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports-VICH GL42- Draft Guidance
| html | | pdf | FR Notice
 

05/02/06

183.

Guidance for Industry- Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction
| html | | pdf | | FR Notice |
 

03/09/07

185.

Draft Guidance for Industry -Target Animal Safety for Veterinary Pharmaceutical Products VICH GL43
| html | | pdf | | FR Notice |
 

05/17/07

187.

Guidance for Industry - Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs
| pdf |
 

01/15/2009

187.

Draft Guidance for Industry - Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs
| html | | pdf |
 

09/18/2008

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
| html | | pdf |  | FR Notice |
 

02/25/2008

191.

Draft Guidance for Industry Changes to Approved NADAs ´┐ŻNew NADAs vs. Category II Supplemental NADAs
| pdf | |FR Notice|
 

12/16/08

192.

Draft Guidance for Industry - Anesthetics for Companion Animals
| pdf | |FR Notice|
 

12/17/08

193.

Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format -- Drug Establishment Registration and Drug Listing pdf |

07/10/2008

194.

Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes | pdf |

08/4/2008

195.

Small Entities Compliance Guide For Renderers´┐ŻSubstances Prohibited From Use In Animal Food Or Feed
| pdf | | FR Notice pre-pub |
 

11/26/2008

196.

Process Validation: General Principles and Practices
| html | | pdf | FR Notice
 

11/18/2008

Web Page Updated by jmo - January 13, 2009, 1:00 pm ET




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