|
|
|
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Withdrawn pending revisions |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(superceded by Guidance #61) |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 |