|
|
|
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 �New 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�Substances 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 |