Guidance by Number
CVM Guidances
Cross-Cutting Guidances
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
August 28, 2024 - CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology
August 28, 2024 - 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 25, 2024 - 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) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Toxicity Testing (Revision 1)
May 23, 2024 - CVM GFI #116 (VICH GL23 (R2)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)
September 30, 2024 - 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
April 29, 2024 - 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 #187A Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach
May 2, 2024 - CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process
May 2, 2024 - CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
January 31, 2024 - 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
January 31, 2024 - 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 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies
September 17, 2024 - 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
June 26, 2024 - CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications
June 21, 2024 - 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 21, 2024 - 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
June 26, 2024 - CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food
November 30, 2023 - CVM GFI #285 - Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs
March 18, 2024 - CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products
January 25, 2024 - CVM GFI #287 - Raw Data for Safety and Effectiveness Studies
April 29, 2024 - CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use
June 24, 2024 - CVM GFI #290 (VICH GL61) – Pharmaceutical Development
May 6, 2024 - CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles
June 24, 2024 - CVM GFI #293 - FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients
August 9, 2024 - CVM GFI #294 - Animal Food Ingredient Consultation (AFIC)
August 9, 2024
Cross-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
October 2, 2024 - 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 FD&C Act
February 6, 2024 - 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