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                Guidance for Industry

Guidance for Industry

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Guidance by Number

CVM GFI #3 General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals
	May 10, 2022
	CVM GFI #5 Drug Stability Guidelines
	December 9, 2008
	CVM GFI #13 Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds-Medicated Block
	January 1, 1985
	CVM GFI #23 Medicated Free Choice Feeds--Manufacturing Control
	July 1, 1985
	CVM GFI #24 Drug Combinations for Use in Animals
	October 1, 1983
	CVM GFI #35 Bioequivalence Guidance
	November 8, 2006
	CVM GFI #37 Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for Pigmentation
	March 1, 1984
	CVM GFI #38 Guideline for Effectiveness Evaluation of Topical/Otic Animal Drugs
	August 21, 1984
	CVM GFI #45 Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle
	August 1, 1993
	CVM GFI #49 Target Animal Safety And Drug Effectiveness Studies for Anti-Microbial Bovine Mastitis Products (Lactating and Non-Lactating Cow Products)
	April 4, 1996
	CVM GFI #53 Evaluation of the Utility of Food Additives in Diet Fed to Aquatic Animals
	May 1, 1994
	CVM GFI #55 Supportive Data for Cat Food Labels Bearing "Reduces Urinary pH Claims": Protocol Development
	June 1, 1994
	CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials
	July 10, 2001
	CVM GFI #57 Preparation and Submission of Veterinary Master Files
	January 1, 1995
	CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species
	December 22, 2023
	CVM GFI #62 Consumer Directed Broadcast Advertisements
	August 1, 1999
	CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology
	July 1, 1999
	CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology: Final Guidance
	July 1, 1999
	CVM GFI #65 Industry Supported Scientific and Educational Activities
	November 1, 1997
	CVM GFI #67 Small Entities Compliance Guide for Renderers
	February 1, 1998
	CVM GFI #68 Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors
	February 1, 1998
	CVM GFI #69 Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations
	February 1, 1998
	CVM GFI #70 Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations
	July 13, 2009
	CVM GFI #72 GMP'S For Medicated Feed Manufacturers Not Required to Register and be Licensed with FDA
	May 1, 1998
	CVM GFI #73 (VICH GL3(R)) Stability Testing of New Veterinary Drug Substances and Medicinal Products
	November 21, 2007
	CVM GFI #74 (VICH GL4 ) Stability Testing of New Veterinary Dosage Forms
	September 1, 1999
	CVM GFI #75 (VICH GL5) Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products
	September 1, 1999
	CVM GFI #76 Questions and Answers BSE Feed Regulations
	July 1, 1998
	CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM
	May 29, 2014
	CVM GFI #80 Evaluation the Utility of Anti-Salmonella Chemical Food Additives
	November 21, 2002
	CVM GFI #82 Development of Supplemental Applications for Approved New Animal Drugs
	October 28, 2002
	CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA
	May 30, 2007
	CVM GFI #85 (VICH GL9) Good Clinical Practice
	May 9, 2001
	CVM GFI #89 (VICH GL6) EIAs for Veterinary Medicinal Products - Phase I
	March 7, 2001
	CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations
	August 12, 2022
	CVM GFI #91 (VICH GL8) Stability Testing for Medicated Premixes
	March 1, 2000
	CVM GFI #92 (VICH GL10(R)) Impurities In New Veterinary Drug Substances
	November 26, 2007
	CVM GFI #93 (VICH GL11(R)) Impurities in New Veterinary Medicinal Products
	November 21, 2007
	CVM GFI #95 (VICH GL12) Effectiveness of Anthelmintics: Specific Recommendations for Bovines
	August 12, 2022
	CVM GFI #96 (VICH GL13) Effectiveness of Anthelmintics: Specific Recommendations for Ovines
	August 12, 2022
	CVM GFI #97 (VICH GL14) Effectiveness of Anthelmintics: Specific Recommendations for Caprines
	August 12, 2022
	CVM GFI #98 Dioxin In Anti-Caking Agents In Animal Feed And Feed Ingredients
	April 12, 2000
	CVM GFI #99 (VICH GL17) Testing of New Biotechnological/Biological Products
	March 26, 2001
	CVM GFI #100 (VICH GL18 (R2)) Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)
	July 18, 2022
	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
	July 10, 2001
	CVM GFI #105 Computerized Systems Used in Clinical Investigations
	CVM GFI #106 The Use of Published Literature in Support of New Animal Drug Approvals
	March 16, 2023
	CVM GFI #108 Registering with CVM’s Electronic Submission System
	April 26, 2023
	CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines
	August 12, 2022
	CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcines
	August 12, 2022
	CVM GFI #111 (VICH GL19) Effectiveness of Anthelmintics: Specific Recommendations for Canines
	August 12, 2022
	CVM GFI #112 Fumonisin Levels in Human Foods and Animal Feeds; Final Guidance
	November 9, 2001
	CVM GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for Felines
	August 12, 2022
	CVM GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Chickens Gallus gallus
	August 12, 2022
	CVM GFI #115 (VICH GL22) Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Toxicity Testing
	July 27, 2006
	CVM GFI #116 (VICH GL23) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing
	August 29, 2002
	CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's)
	May 1, 2006
	CVM GFI #118 Mass Spectrometry for Confirmation of Identity of Animal Drug Residues
	May 1, 2003
	CVM GFI #119 How CVM Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug
	August 29, 2002
	CVM GFI #120 Veterinary Feed Directive Regulation Questions and Answers
	March 28, 2019
	CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores
	November 9, 2004
	CVM GFI #123 Development of Data Supporting Approval of NSAIDS for Use in Animals
	January 5, 2006
	CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation
	June 1, 2006
	CVM GFI #132 Administrative Applications and the Phased Review Process
	May 23, 2018
	CVM GFI #135 Validation of Analytical Procedures for Type C Medicated Feeds
	November 7, 2005
	CVM GFI #136 Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods
	April 26,  2007
	CVM GFI #137 Analytical Methods Description for Type C Medicated Feeds
	May 8, 2007
	CVM GFI #141 (VICH GL28) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing
	July 27, 2006
	CVM GFI #142 (VICH GL29) Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)
	December 6, 2001
	CVM GFI #143 (VICH GL30) Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms
	October 9, 2014
	CVM GFI #144 (VICH GL27) Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial Resistance
	April 27, 2004
	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
	July 27, 2006
	CVM GFI #148 (VICH GL32) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing
	July 27, 2006
	CVM GFI #149 (VICH GL33) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing
	March 17, 2009
	CVM GFI #150 Concerns Related to the use of Clove Oil as an Anesthetic for Fish
	April 24, 2007
	CVM GFI #151 FDA Export Certificates
	July 12, 2004
	CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern
	January 27, 2023
	CVM GFI #156 Comparability Protocols - Chemistry, Manufacturing, and Controls Information for New Animal Drugs
	April 4, 2016
	CVM GFI #158 Use of Material from Deer and Elk in Animal Feed
	March 16, 2016
	CVM GFI #159 (VICH GL36) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI
	January 21, 2022
	CVM GFI #160 (VICH GL37) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing
	July 27, 2006
	CVM GFI #166 (VICH GL38) Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP’s) - Phase II
	January 9, 2006
	CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information
	August 6, 2010
	CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions
	April 13, 2023
	CVM GFI #171 - Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media
	June 16, 2023
	CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)
	February 7, 2005
	CVM GFI #173 Appendix for the Animal Drug Sponsor Fees Under ADUFA
	February 7, 2005
	CVM GFI #176 (VICH GL39) Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances
	June 14, 2006
	CVM GFI #177 (VICH GL40) Test Procedures/Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products
	June 14, 2006
	CVM GFI #178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims
	October 1, 2007
	CVM GFI #179 Use of Animal Clones and Clone Progeny for Human Food and Animal Feed
	January 15, 2008
	CVM GFI #181 Blue Bird Medicated Feed Labels
	July 23, 2019
	CVM GFI #183 Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction
	March 9, 2007
	CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products
	April 24, 2009
	CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals
	January 19, 2017
	CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
	April 23, 2021
	CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs
	August 27, 2020
	CVM GFI #192 Anesthetics for Companion Animals
	March 25, 2010
	CVM GFI #195 Small Entities Compliance Guide For Renderers—Substances Prohibited From Use In Animal Food Or Feed
	May 6, 2009
	CVM GFI #196 Process Validation: General Principles and Practices
	January 24, 2011
	CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs
	November 13, 2020
	CVM GFI #198 (VICH GL45) Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products
	July 31, 2015
	CVM GFI #199 Animal Generic Drug User Fees and Fee Waivers and Reductions
	December 4, 2023
	CVM GFI #200 - Small Entities Compliance Guide Designation of New Animal Drugs for Minor Uses or Minor Species
	July 29, 2014
	CVM GFI #201 SECG for The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
	July 29, 2014
	CVM GFI #203 Ensuring Safety of Animal Feed Maintained and Fed On-Farm
	March 9, 2016
	CVM GFI #204 Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for use in Companion Animals
	December 1, 2015
	CVM GFI #205 (VICH GL46) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals:  Metabolism Study to Determine the Quantity and Identify the Nature of Residues (MRK)
	September 15, 2011
	CVM GFI #206 (VICH GL47) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals
	September 15, 2011
	CVM GFI #207 (VICH GL48) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs In Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods
	March 9, 2015
	CVM GFI #208 (VICH GL49) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies
	March 9, 2015
	CVM GFI #209 The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals
	April 13, 2012
	FDA's Strategy on Antimicrobial Resistance - Questions and Answers
	December 11, 2013
	CVM GFI #211 Residual Solvents in Animal Drug Products Questions and Answers
	April 3, 2015
	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
	December 12, 2013
	CVM GFI #214 (VICH GL35) Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data
	December 10, 2014
	CVM GFI #215 Target Animal Safety and Effectiveness Protocol Development and Submission
	September 29, 2011
	CVM GFI #216 Chemistry, Manufacturing, and Controls (CMC) Information - Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use
	March 8, 2012
	CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals
	November 20, 2012
	CVM GFI #218 Cell-Based Products for Animal Use
	June 12, 2015
	CVM GFI #219 (VICH GL51) Statistical Evaluation of Stability Data
	May 13, 2014
	CVM GFI #220 Use of Nanomaterials in Food for Animals
	August 5, 2015
	CVM GFI #221 Recommendations for Preparation and Submission of Animal Food Additive Petitions
	June 12, 2015
	CVM GFI #223 Small Entity Compliance Guide Declaring Color Additives in Animal Foods
	September 27, 2013
	CVM GFI #224 (VICH GL52) Bioequivalence: Blood Level Bioequivalence Study
	December 16, 2016
	CVM GFI #224 (Supplement to VICH GL52) Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Guidance GL52
	September 24, 2014
	CVM GFI #225 (VICH GL53) Electronic Exchange of Documents: File Format Recommendations
	September 1, 2015
	CVM GFI #226 Target Animal Safety Data Presentation and Statistical Analysis
	January 21, 2016
	CVM GFI #227 Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections
	September 1, 2015
	CVM GFI #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle
	October 19, 2015
	CVM GFI #231 Distributor Labeling for New Animal Drugs
	April 20, 2016
	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)
	August 23, 2017
	CVM GFI #233 Veterinary Feed Directive Common Format Questions and Answers
	September 22, 2016
	CVM GFI #234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications
	December 20, 2016
	CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals
	October 20, 2017
	CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products
	October 5, 2017
	CVM GFI #237 Oncology Drugs for Companion Animals
	August 23, 2017
	CVM GFI #238 Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications
	June 17, 2016
	CVM GFI #239 Human Food By-Products For Use As Animal Food
	August 25, 2016
	CVM GFI #240 Proprietary Names for New Animal Drugs
	June 1, 2020
	CVM GFI #241 Small Entity Compliance Guide – What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507)
	November 1, 2016
	CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products
	November 27, 2020
	CVM GFI #243 (VICH GL56) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods
	November 14, 2018
	CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
	July 8, 2022
	CVM GFI #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program
	June 15, 2018
	CVM GFI #252 Small Entity Compliance Guide Antimicrobial Animal Drug Sales and Distribution Reporting
	June 29, 2018
	CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products
	October 20, 2022
	CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products
	October 20, 2022
	CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers
	November 23, 2020
	CVM GFI #256 Compounding Animal Drugs from Bulk Drug Substances
	August 10, 2022
	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
	August 19, 2019
	CVM GFI #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds
	October 19, 2022
	CVM GFI #259 (VICH GL58) Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV
	April 14, 2020
	CVM GFI #261 Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs
	July 14, 2021
	CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices
	December 11, 2020
	CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter
	June 11, 2021
	CVM GFI #264 Standardized Medicated Feed Assay Limits
	February 27, 2020
	CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs
	October 6, 2021
	CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs
	October 6, 2021
	CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs
	October 6, 2021
	CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs
	October 6, 2021
	CVM GFI #271 Reporting and Mitigating Animal Drug Shortages
	May 12, 2023
	CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover
	January 30, 2023
	CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals
	September 26, 2023
	CVM GFI #276 Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs
	November 30, 2022
	CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications
	April 5, 2023
	CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting
	June 8, 2023
	CVM GFI #281 Infectious Otitis Externa Drugs for Topical Use in Dogs
	March 31, 2023
	CVM GFI #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals
	September 15, 2023
	CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process
	December 18, 2023
	CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food
	November 30, 2023
	CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products
	January 25, 2024Cross-Cutting Guidances

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
	June 29, 2010
	Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs
	August 5, 2015
	Conducting Remote Regulatory Assessments Questions and Answers
	January 26, 2024
	Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry
	April 14, 2016
	Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA
	November 1, 2016
	Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices
	June 6, 2014
	Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices - Revised Guidance
	February 28, 2014
	Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
	March 16, 2023
	Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996
	July 23, 2007
	Small Entity Compliance Guide: Registration of Food Facilities
	May 29, 2018
	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)
	May 24, 2010
	Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
	August 1, 2018
	Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP_PRA
	January 11, 2006
	Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
	January 13, 2014
	Guidance for Industry: Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal Food
	October 1, 2016
	Draft Guidance for Industry: Best Practices for Convening a GRAS Panel
	November 1, 2017
	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
	November 1, 2017
	Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry
	July 10, 2019
	Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff
	March 4, 2022
	Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
	June 17, 2014
	Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
	June 17, 2014
	Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (2016 Edition)
	September 1, 2016
	PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
	September 29, 2004
	Pharmaceutical Components at Risk for Melamine Contamination
	August 6, 2009
	Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)
	January 19, 2021
	Postapproval Changes to Drug Substances Guidance for Industry
	September 10, 2018
	Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements
	June 27, 2023
	Presenting Risk Information in Prescription Drug and Medical Device Promotion
	May 27, 2009
	Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)
	June 1, 2016
	Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling
	December 11, 2017
	Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
	April 4, 2014
	Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing
	May 28, 2009
	Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls
	November 23, 2020
	Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C
	February 8, 2019
	Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
	October 26, 2023
	Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide
	October 29, 2021
	Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act
	October 29, 2021
	Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
	December 27, 2011
	Guidance for Industry: Sanitary Transportation of Food
	April 30, 2010
	Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
	February 25, 2010
	Guidance for Industry: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods
	March 1, 2012
	Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants
	January 19, 2001
	Guidance for Industry: FDA's Voluntary Qualified Importer Program
	June 3, 2015
	Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide
	April 4, 2014

                                                                                  Content current as of:
      01/30/2024Guidance for Industry

          
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