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Published Guidance Documents

1-50 | 51 - 100 | 101 -150 | 151 - 174 |

No.

Title

Date

1.

Anticoccidial Guidelines

replaced by Guideline #40

2.

Anthelmintics

 

3.

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

07/94
See Guidance 118 for update to Section V.B1

4.

Guidelines for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle

 

5.

Stability Guidelines

12/90

6.

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

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

8.

Guidelines for Toxicological Investigations

replaced by Guideline number 3

9.

Preclearance Guidelines for Production Drugs

Withdrawn pending revisions

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

14.

Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Food Producing Animals

 

15.

Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing Animals (2277)

 

16.

FOI Summary Guideline

05/85

17.

Working Guidelines for Assigning Residue Tolerances

replaced by Guideline number 3

18.

Antibacterial Drugs in Animal Feeds: Human Health Safety Criteria

 

19.

Antibacterial Drugs in Animal Feeds: Animal Health Safety Criteria

 

20.

Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness Criteria

 

21.

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

25.

Guidelines for the Efficacy Evaluation of Equine Anthelmintics Replaced by Guidance 109

 

26.

Guidelines for the Preparation of Data to Satisfy the Requirements of Section 512 of the Act Regarding Animal Safety, Effectiveness, Human Food Safety and Environmental Considerations for Minor Use of New Animal Drugs
(superceded by Guidance #61)

04/86;
see also Guideline 61, below.

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

29.

Guidelines for the Effectiveness Evaluation of Swine Anthelmintics

09/80

30.

Guidelines for Anti-infective Bovine Mastitis Product Development

replaced by guideline #49

31.

Guidelines for the Evaluation of Bovine Anthelmintics

(07/81)

32.

Guideline for Threshold Assessment

replaced by Guideline number 3

33.

Target Animal Safety Guidelines for New Animal Drugs

06/89

34.

Biomass Guideline - Guideline for New Animal Drugs and Food Additives Derived From a Fermentation; Human Food Safety Evaluation

replaced by Guideline number 3

35.

Bioequivalence Guideline, | pdf | | doc |

revised 10/09/02

36.

Guidelines for Efficacy Evaluation of Canine/Feline Anthelmintics

07/85

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

08/84

39.

Guideline on the Conduct of Clinical Investigations: Responsibilities of Clinical Investigators and Monitors for Investigational New Animal Drug Studies

10/92;
replaced by Guidance number 58

40.

Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in Poultry

04/92

41.

Draft Guideline: Formatting, Assembling, and Submitting New Animal Drug Applications

06/92

42.

Series of four guidelines entitled "Animal Drug Manufacturing Guidelines"

1994

43.

Draft Guideline for Generic Animal Drug Products Containing Fermentation-Derived Drug Substances

10/95

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

51.

Points to Consider Guideline - Development of a Pharmacokinetic Guideline Enabling Flexible Labeling of Therapeutic Antimicrobials

"Please see Guidance 66 for updated information."

52.

Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora, February 18, 2004 | pdf | | doc |

02/18/04

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 | | html |

07/10/01

57.

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

1995

58.

Guidance for Industry for Good Target Animal Study Practices: Clinical Investigators and Monitors

05/97

59.

Guidance for Industry: How to Submit a Notice of Claimed Investigational Exemption in Electronic Format by E-Mail
| doc | | pdf |

05/21/04

60.

Guidance For Industry: Animal Proteins Prohibited From Animal Feed; Small Entity Compliance Guide

Replaced by Guidance 67, 68, 69, and 70

61.

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

04/99

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

07/99

64.

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

07/99

65.

Guidance for Industry: Industry-Supported Scientific and Educational Activities

11/97

66.

Withdrawal of Guidance Document on Professional Flexible Labeling of Antimicrobial Drugs

01/02

67.

Guidance for Industry: Small Entities Compliance Guide for Renderers

02/98

67.

Guía de la FDA para la Industria Número 67: Para Extractores de Grasa por Fusión
|docl | |pdf|

02/98

68.

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

02/98

68.

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

|docl | | pdf |

02/09

69.

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

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 | docl | | pdf |

02/98

70.

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

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 | docl | | 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 | | text |

05/98

73.

Guidance For industry: Stability Testing Of New Veterinary Drug Substances And Medicinal Products VICH GL3: FINAL GUIDANCE
| pdf | | text |

09/99

74.

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

09/99

75.

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

09/99

76.

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

07/98

77.

Guidance for Industry: Interpretation of On-Farm Feed Manufacturing and Mixing Operations: DRAFT GUIDANCE | htm | | pdf |

Withdrawn 06/12/2003

78.

Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals
| pdf | | html |

12/99

79.

Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (CVM) - Draft Guidance | pdf | | doc |

05/16/03

80.

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

11/21/02

82.

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

10/28/02

83.

Guidance for Industry: Chemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA:
DRAFT GUIDANCE
| pdf | | wpd |

 06/99

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
| pdf | | doc |

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 by E-Mail
| doc | | pdf |

05/21/04

87.

Guidance for Industry - How to Submit a Notice of Intent to Slaughter for Human Food Purposes in Electronic Format by E-mail
| pdf | | doc |

05/21/04

88.

Guidance for Industry - How to Submit a Request for a Meeting or Teleconference in Electronic Format by E-mail
| doc | | pdf |

05/21/04

89.

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

03/07/01

90.

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

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
| pdf | |doc |

03/00

92.

Guidance for Industry: Impurities In New Veterinary Drug Substances
| pdf | | doc |

07/99

93.

Guidance for Industry: Impurities In New Veterinary Medical Products
| pdf | | doc |

07/99

95.

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

03/26/01

96.

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

03/26/01

97.

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

03/26/01

98.

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

Revised 04/14/00

99.

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

03/26/01

100.

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

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
| pdf | | doc |

 07/10/01

105.

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

10/99

106.

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

08/31/00

107.

Guidance for Industry: How to Submit a Protocol in Electronic Format by E-Mail
| pdf | | doc |

05/21/04

108.

Guidance for Industry: How to Submit Information in Electronic Format by E-Mail
| pdf | | doc |

05/21/04

109.

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

06/27/02

110.

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

06/27/02

111.

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

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
| doc | | pdf |

06/19/02

114.

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

06/19/02

115.

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

01/03/02

116.

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

01/03/02

117.

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

12/12/00

118.

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

08/29/02

120.

Guidance for Industry - Veterinary Feed Directive Regulation
| doc | | pdf |

03/01/01

121.

Guidance for Industry - Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims
| doc | | pdf |

03/06/01

122.

Guidance for Industry - Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores
| doc | | pdf |

05/18/04

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, February 2001
| html | | pdf |

02/01

132.

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

11/06/02

135

Guidance for Industry - Validation of Analytical Procedures for Type C Medicated Feeds - Draft Guidance
|doc| |pdf|

04/26/04

141.

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

05/24/04

142.

CVM Guidance for Industry #142: Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) - VICH GL29 - Draft Guidance
| doc | pdf |

12/12/01

143.

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

02/01/02

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 | 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, | doc | | pdf |

11/12/03

148.

Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing - VICH GL32 Final Guidance | doc | | pdf |

03/19/04

149.

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

05/18/04

150.

Guidance for Industry: Status of Clove Oil and Eugenol for Anesthesia of Fish | pdf | | doc |

06/11/02

151.

Guidance for Industry: FDA Export Certificates
| htm | | 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

09/02

154.

Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records | htm | | pdf |

Withdrawn
02/25/03

155.

Draft Guidance for Industry: 21 CFR Part 11: Electronic Records; Electronic Signatures; Electronic Copies of Electronic Records
| htm | | pdf |

Withdrawn
02/04/03

156.

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

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 | doc | | pdf |

09/15/03

159.

Draft Guidance for Industry 159 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI - VICH GL-36, | doc | | pdf |

11/12/03

160.

Draft Guidance for Industry - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing, VICH GL-37 | doc | | pdf |

10/17/03

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

Draft Guidance for Industry #166 - Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's) - Phase II - VICH GL38, | pdf | | doc |

04/20/04

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 | pdf | | doc |

01/04

170.

Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions, Final Guidance, March 15, 2004
|pdf | | doc |

3/15/04

171

Draft 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, August 2004
| pdf | | doc |

8/04

172.

Guidance for Industry - Use of unapproved hormone implants in veal calves, April 2, 2004
|htm||  |pdf|

Withdrawn 07/15/04

173.

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

09/28/04

174.

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

09/30/04

 

Web page updated by swd, October 6, 2004, 5:50 PM ET

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