Animal & Veterinary

Guidance by Number

CVM Guidances
Cross-Cutting Guidances

     

Guidance by Number

TitleIssued Date
CVM GFI #3 General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals (PDF - 390KB) 06/12/18
CVM GFI #5 Drug Stability Guidelines (PDF - 385KB) 12/09/08
CVM GFI #13 Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds-Medicated Block 01/01/85
CVM GFI #23 Medicated Free Choice Feeds--Manufacturing Control 07/01/85
CVM GFI #24 Drug Combinations for Use in Animals 10/01/83
CVM GFI #35 Bioequivalence Guidance (PDF - 182KB) 11/08/06
CVM GFI #37 Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for Pigmentation 03/01/84
CVM GFI #38 Guideline for Effectiveness Evaluation of Topical/Otic Animal Drugs 08/21/84
CVM GFI #42 Animal Drug Manufacturing Guidelines- Series of Four Guidelines 01/01/94
CVM GFI #45 Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle 08/01/93
CVM GFI #49 Target Animal Safety And Drug Effectiveness Studies for Anti-Microbial Bovine Mastitis Products (Lactating and Non-Lactating Cow Products) 04/04/96
CVM GFI #50 Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products 02/01/93
CVM GFI #53 Evaluation of the Utility of Food Additives in Diet Fed to Aquatic Animals 05/01/94
CVM GFI #55 Supportive Data for Cat Food Labels Bearing "Reduces Urinary pH Claims: Protocol Development 06/01/94
CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials (PDF - 60KB) 07/10/01
CVM GFI #57 Preparation and Submission of Veterinary Master Files (PDF - 110KB) 01/01/95
CVM GFI #61 FDA Approval of New Animal Drugs for MUMS (PDF - 507KB) 05/29/08
CVM GFI #62 Consumer Directed Broadcast Advertisements 08/01/99
CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology (PDF - 118KB) 07/01/99
CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology: Final Guidance (PDF - 218KB) 07/01/99
CVM GFI #65 Industry Supported Scientific and Educational Activities (PDF - 428KB) 11/01/97
CVM GFI #67 Small Entities Compliance Guide for Renderers (PDF - 66KB) 02/01/98
CVM GFI #68 Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors (PDF - 66KB) 02/01/98
CVM GFI #69 Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations (PDF - 62KB) 02/01/98
CVM GFI #70 Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations (PDF - 59KB) 07/13/09
CVM GFI #72 GMP'S For Medicated Feed Manufacturers Not Required to Register and be Licensed with FDA (PDF - 57KB) 05/01/98
CVM GFI #73 (VICH GL3(R)) Stability Testing Of New Veterinary Drug Substances (PDF - 228KB) 11/21/07
CVM GFI #74 (VICH GL4 ) Stability Testing of New Veterinary Dosage Forms (PDF - 79KB) 09/01/99
CVM GFI #75 (VICH GL5) Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products (PDF - 76KB) 09/01/99
CVM GFI #76 Questions and Answers BSE Feed Regulations (PDF - 152KB) 07/01/98
CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM (PDF - 139KB) 05/29/14
CVM GFI #80 Evaluation the Utility of Anti-Salmonella Chemical Food Additives (PDF - 78KB) 11/21/02
CVM GFI #82 Development of Supplemental Applications for Approved New Animal Drugs (PDF - 843KB) 10/28/02
CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA (PDF - 162KB) 05/30/07
CVM GFI #85 (VICH GL9) Good Clinical Practice (PDF - 356KB) 05/09/01
CVM GFI #89 (VICH GL6) EIAs for Veterinary Medicinal Products - Phase I (PDF - 106KB) 03/07/01
CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations (PDF - 98KB) 10/11/01
CVM GFI #91 (VICH GL8) Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products on Stability Testing for Medicated Premixes (PDF - 47KB) 03/01/00
CVM GFI #92 (VICH GL10(R)) Impurities In New Veterinary Drug Substances (PDF - 150KB) 11/26/07
CVM GFI #93 (VICH GL11(R)) Impurities in New Veterinary Medicinal Products (PDF - 134KB) 11/21/07
CVM GFI #95 (VICH GL12) Efficacy of Anthelmintics: Specific Recommendations for Bovines (PDF - 96KB) 03/26/01
CVM GFI #96 (VICH GL13) Efficacy of Anthelmintics: Specific Recommendations for Ovines (PDF - 86KB) 03/26/01
CVM GFI #97 (VICH GL14) Efficacy of Anthelmintics: Specific Recommendations for Caprines (PDF - 90KB) 03/26/01
CVM GFI #98 Dioxin In Anti-Caking Agents In Animal Feed And Feed Ingredients (PDF - 35KB) 04/12/00
CVM GFI #99 (VICH GL17) Testing of New Biotechnological/Biological Products (PDF - 118KB) 03/26/01
CVM GFI #100 (VICH GL18) Residual Solvents in New Veterinary Medicinal Products (PDF - 164KB) 11/02/11
CVM GFI #102 Manufacture and Distribution of Unapproved Piperazine Products 08/27/99
CVM GFI #103 Possible Dioxin/PCB Contamination of Drug and Biological Products
CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission (PDF - 174KB) 07/10/01
CVM GFI #105 Computerized Systems Used in Clinical Investigations
CVM GFI #106 Published Literature in Support of New Animal Drug Approval (PDF - 41KB) 08/31/00
CVM GFI #108 Registering with CVM’s Electronic Submission System (PDF - 220KB) 05/22/18
CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equine (PDF - 199KB) 06/27/02
CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcine (PDF - 196KB) 06/27/02
CVM GFI #111 (VICH GL19) Effectiveness of Anthelmintics: Specific Recommendations for Canine (PDF - 214KB) 06/27/02
CVM GFI #112 Fumonisin Levels in Human Foods and Animal Feeds; Final Guidance 11/09/01
CVM GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for Feline (PDF - 227KB) 06/19/02
CVM GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Poultry-Gallus Gallus (PDF - 201KB) 06/19/02
CVM GFI #115 (VICH GL22) Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Toxicity Testing (PDF - 104KB) 07/27/06
CVM GFI #116 (VICH GL23) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (PDF - 222KB) 05/13/15
CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's) (PDF - 121KB) 05/01/06
CVM GFI #118 Mass Spectrometry for Confirmation of Identity of Animal Drug Resides (PDF - 112KB) 05/01/03
CVM GFI #119 How CVM Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug (PDF - 33KB) 08/29/02
CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers (PDF - 124KB) 09/30/15
CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores (PDF - 94KB) 11/09/04
CVM GFI #123 Development of Data Supporting Approval of NSAIDS for Use in Animal (PDF - 52KB) 01/05/06
CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation (PDF - 134KB) 06/01/06
CVM GFI #132 Administrative Applications and the Phased Review Process (PDF - 86KB) 05/23/18
CVM GFI #135 Validation of Analytical Procedures for Type C Medicated Feeds (PDF - 107KB) 11/07/05
CVM GFI #136 Method Transfer Studies for Type C Medicated Feed Assay Methods (PDF - 105KB) 04/26/07
CVM GFI #137 Analytical Methods Description for Type C Medicated Feeds (PDF - 94KB) 05/08/07
CVM GFI #141 (VICH GL28) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing (PDF - 83KB) 07/27/06
CVM GFI #142 (VICH GL29) Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) (PDF - 152KB) 12/06/01
CVM GFI #143 (VICH GL30) Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms (PDF - 149KB) 10/09/14
CVM GFI #144 (VICH GL27) Pre-Approval for Registration of New VMPs for Food-Producing Animals to Antimicrobial Resistance (PDF - 180KB) 04/27/04
CVM GFI #145 Bioanalytical Method Validation
CVM GFI #147 (VICH GL31) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat Dose (90 Day) Toxicity Testing (PDF - 102KB) 07/27/06
CVM GFI #148 (VICH GL32) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing (PDF - 52KB) 07/27/06
CVM GFI #149 (VICH GL33) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing (PDF - 171KB) 03/17/09
CVM GFI #150 Concerns Related to the use of Clove Oil as an Anesthetic for Fish (PDF - 41KB) 04/24/07
CVM GFI #151 FDA Export Certificates 07/12/04
CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern (PDF - 474KB) 10/23/03
CVM GFI #156 Comparability Protocols - Chemistry, Manufacturing, and Controls Information for New Animal Drugs (PDF - 111KB) 04/04/16
CVM GFI #158 Use of Material from Deer and Elk in Animal Feed (PDF - 24KB) 03/16/16
CVM GFI #159 (VICH GL36) Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (PDF - 533KB) 03/05/13
CVM GFI #160 (VICH GL37) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing (PDF - 75KB) 07/27/06
CVM GFI #166 (VICH GL38) EIA's for Veterinary Medicinal Products, Phase II (PDF - 427KB) 01/09/06
CVM GFI #169 Drug Substance: Chemistry, Manufacturing, and Controls Information (PDF - 363KB) 08/06/10
CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions (PDF - 172KB) 07/25/17
CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA) (PDF - 52KB) 02/07/05
CVM GFI #173 Appendix for the Animal Drug Sponsor Fees Under the ADUFA (PDF - 44KB) 02/07/05
CVM GFI #176 (VICH GL39) Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances (PDF - 277KB) 06/14/06
CVM GFI #177 (VICH GL40) Test Procedures/Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Product (PDF - 286KB) 06/14/06
CVM GFI #178 Design/Evaluation of Effectiveness Studies - Swine Respiratory Disease Claims (PDF - 140KB) 10/01/07
CVM GFI #179 Use of Animal Clones and Clone Progeny for Human Food/Animal Feed (PDF - 52KB) 01/15/08
CVM GFI #181 Blue Bird Medicated Feed Labels (PDF - 91KB) 09/29/15
CVM GFI #183 ADUFA- Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction (PDF - 117KB) 03/09/07
CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products (PDF - 395KB) 04/24/09
CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals (PDF - 200KB) 01/19/17
CVM GFI #188 Guidance for Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine (PDF - 255KB) 10/09/14
CVM GFI #191 New NADAs vs. Category II Supplemental NADAs (PDF - 183KB) 05/07/15
CVM GFI #192 Anesthetics for Companion Animals (PDF - 177KB) 03/25/10
CVM GFI #195 Small Entities Compliance Guide For Renderers—Substances Prohibited From Use In Animal Food Or Feed (PDF - 251KB) 05/06/09
CVM GFI #196 Process Validation: General Principles and Practices (PDF - 372KB) 01/24/11
CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs (PDF - 110KB) 05/21/18
CVM GFI #198 (VICH GL45) Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products (PDF - 142KB) 07/31/15
CVM GFI #199 Animal Generic Drug User Fees and Fee Waivers and Reductions (PDF - 87KB) 05/13/09
CVM GFI #200 - Small Entities Compliance Guide Designation of New Animal Drugs for Minor Uses/Minor Species (PDF - 71KB) 07/29/14
CVM GFI #201 SECG for Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (PDF - 296KB) 07/29/14
CVM GFI #203 Ensuring Safety of Animal Feed Maintained and Fed On-Farm (PDF - 108KB) 03/09/16
CVM GFI #204 Active Controls in Studies to Demonstrate Effectiveness of a NAD for use in Companion Animals (PDF - 181KB) 12/01/15
CVM GFI #205 (VICH GL46) Metabolism Study to Determine the Quantity and Identify the Nature of Residues (PDF - 210KB) 09/15/11
CVM GFI #206 (VICH GL47) Comparative Metabolism Studies In Laboratory Animals (PDF - 138KB) 09/15/11
CVM GFI #207 (VICH GL48) Marker Residue Depletion Studies to Establish Product Withdrawal Periods (PDF - 303KB) 03/09/15
CVM GFI #208 (VICH GL49) Validation of Analytical Methods Used in Residue Depletion Studies (PDF - 291KB) 03/09/15
CVM GFI #209 The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (PDF - 256KB) 04/13/12
FDA's Strategy on Antimicrobial Resistance - Questions and Answers 12/11/13
CVM GFI #210 The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (PDF - 239KB) 04/27/18
CVM GFI #211 Residual Solvents Q (PDF - 76KB) 04/03/15
CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (PDF - 115KB) 12/12/13
CVM GFI #214 (VICH GL35) Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data (PDF - 1.5MB) 12/10/14
CVM GFI #215 Target Animal Safety and Effectiveness Protocol Development and Submission (PDF - 63KB) 09/29/11
CVM GFI #216 CMC Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use (PDF - 78KB) 03/08/12
CVM GFI #217 Effectiveness of Anticoccidial Drugs in Food-Producing Animals (PDF - 181KB) 11/20/12
CVM GFI #218 Cell-Based Products for Animal Use (PDF - 162KB) 06/12/15
CVM GFI #219 (VICH GL51) Statistical Evaluation of Stability Data (PDF - 221KB) 05/13/14
CVM GFI #220 Use of Nanomaterials in Food for Animals (PDF - 86KB) 08/05/15
CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions (PDF - 122KB) 06/12/15
CVM GFI #223 Small Entity Compliance Guide Declaring Color Additives in Animal Foods (PDF - 48KB) 09/27/13
CVM GFI #224 (VICH GL52) Bioequivalence: Blood Level Bioequivalence Study (PDF - 283KB) 12/16/16
CVM GFI #224 (Supplement to VICH GL52) Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Draft Guidance GL52 (PDF - 167KB) 09/24/14
CVM GFI #225 (VICH GL53) Electronic Exchange of Documents: File Format Recommendations (PDF - 113KB) 09/01/15
CVM GFI #226 Target Animal Safety Data Presentation and Statistical Analysis (PDF - 561KB) 01/21/16
CVM GFI #227 Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections (PDF - 105KB) 09/01/15
CVM GFI #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle (PDF - 128KB) 10/19/15
CVM GFI #231 Distributor Labeling for New Animal Drugs (PDF - 85KB) 04/20/16
CVM GFI #232 (VICH GL54) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD) (PDF - 100KB) 08/23/17
CVM GFI #233 Veterinary Feed Directive Common Format Questions and Answers (PDF - 834KB) 09/22/16
CVM GFI #234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section Of Animal Drug Applications (PDF - 614KB) 12/20/16
CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals (PDF - 362KB) 10/20/17
CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products (PDF - 85KB) 10/05/17
CVM GFI #237 Oncology Drugs for Companion Animals (PDF - 198KB) 08/23/17
CVM GFI #238 Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications (PDF - 164KB) 06/17/16
CVM GFI #239 Human Food By-Products For Use As Animal Food (PDF - 146KB) 08/25/16
CVM GFI #240 Proprietary Names for New Animal Drugs (PDF - 164KB) 03/12/18
CVM GFI #241 Small Entity Compliance Guide - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PDF - 238KB) 11/01/16
CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products (PDF - 111KB) 01/04/17
CVM GFI #243 (VICH GL56) Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods (PDF - 214KB) 01/05/17
CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (PDF - 1.2MB) 01/23/18
CVM GFI #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program (PDF - 301KB) 06/15/18
CVM GFI #252 Antimicrobial Animal Drug Sales and Distribution Reporting (PDF - 34KB) 06/29/18
CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers (PDF - 192KB) 03/27/18
CVM GFI #257 (VICH GL57) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species (PDF - 152KB) 07/24/18

     

Cross-Cutting Guidances

TitleIssued Date
Guidance for Industry and FDA: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal Feed 06/29/10
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs (PDF - 303KB) 08/05/15
Bioanalytical Method Validation Guidance for Industry (PDF - 386KB) 05/21/18
Guidance for Industry: Computerized Systems Used in Clinical Investigations (PDF - 53KB) 05/10/07
Consumer-Directed Broadcast Advertisements 08/01/99
Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 120KB) 04/14/16
Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA 11/01/16
Direct-to-Consumer Television Advertisements -- FDAAA DTC Television Ad Pre-Dissemination Review Program (PDF - 314KB) 03/12/12
Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices (PDF - 95KB) 06/06/14
Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices - Revised Guidance (PDF - 150KB) 02/28/14
FDA Export Certificates 07/12/04
Exports Under the FDA Export Reform and Enhancement Act of 1996 07/23/07
Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds 11/09/01
Guidance for Industry: Registration of Food Facilities: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide 12/12/12
Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2) 05/24/10
Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) 08/01/18
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA (PDF - 66KB) 01/11/06
Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (PDF - 118KB) 01/13/14
Guidance for Industry: Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal Food 10/01/16
Draft Guidance for Industry: Best Practices for Convening a GRAS Panel 11/01/17
Guidance for Industry: Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic Act 11/01/17
Guidance for Industry: Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators 08/28/12
Industry Supported Scientific and Educational Activities (PDF - 428KB) 11/01/97
Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (PDF - 176KB) 06/17/14
Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (PDF - 136KB) 06/17/14
Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition) 09/01/16
PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF - 211KB) 09/29/04
Pharmaceutical Components at Risk for Melamine Contamination (PDF - 137KB) 08/06/09
Postapproval Changes to Drug Substances Guidance for Industry (PDF - 393KB) 09/10/18
Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 933KB) 05/27/09
Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3) 06/01/16
Process Validation: General Principles and Practices (PDF - 372KB) 01/24/11
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 115KB) 12/11/17
Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act 04/04/14
Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (PDF - 103KB) 05/28/09
Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls (PDF - 60KB) 09/26/18
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF - 302KB) 12/27/11
Guidance for Industry: Sanitary Transportation of Food 04/30/10
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB) 02/25/10
Guidance for Industry: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods 03/01/12
Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants 01/19/01
Guidance for Industry: FDA's Voluntary Qualified Importer Program 06/03/15
Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide 04/04/14

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