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  1. Guidance for Industry

Guidances Under Development

Center for Veterinary Medicine (CVM) Guidance Documents Under Development for 2025

(Expected to publish as drafts or finals by the end of December 2025.)

Introduction

The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the CVM is considering. We currently intend to develop guidance on each topic; however, the Center is neither bound by this list of topics, nor required to issue every guidance document on this list. We are not precluded from developing guidance documents on topics not on this list. This list includes Compliance Policy Guides.

Guidance for Industry (GFI)

Title of GuidanceContact
GFI #49 – Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis (Revision)Paulette Salmon, Center for Veterinary Medicine (Division of Food Animal Drugs), 7500 Standish Place, Rockville, MD 20855, 240-402-6556, paulette.salmon@fda.hhs.gov
Draft GFI #80 – Utility Studies for Anti-Salmonella Animal Food Additives (Revision)Jianli Dai, Center for Veterinary Medicine (Division of Animal Food Ingredients), 7500 Standish Place, Rockville, MD 20855, 240-402-7462, jianli.di@fda.hhs.gov
GFI #120 – Veterinary Feed Directive Regulation Questions and Answers (Revision)Kelly Louviere, Center for Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855, 240-402-5815, kelly.louviere@fda.hhs.gov
GFI #135 – Validation of Analytical Procedures for Type C Medicated Feeds (Revision)Kevin Cheng, Center for Veterinary Medicine (Generic Drug Manufacturing Branch 3), 7500 Standish Place, Rockville, MD 20855, 301-796-8865, kevin.cheng@fda.hhs.gov
GFI #137 – Analytical Methods Description for Type C Medicated Feeds (Revision)Kevin Cheng, Center for Veterinary Medicine (Generic Drug Manufacturing Branch 3), 7500 Standish Place, Rockville, MD 20855, 301-796-8865, kevin.cheng@fda.hhs.gov 
GFI #152 – Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern (Revision)Ruby Singh, Center for Veterinary Medicine (HFV-150), 7500 Standish Pl., Rockville, MD  20855, 240-402-0794, ruby.singh@fda.hhs.gov
Final GFI #187B – Heritable Intentional Genomic Alterations in Animals: The Approval ProcessAskCVM@fda.hhs.gov
Draft GFI #210 – The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (Revision)Lucy Lee, Center for Veterinary Medicine (HFV-50), 7500 Standish Place, Rockville, MD 20855, 240-402-0563, lucy.lee@fda.hhs.gov
Draft GFI #217 – Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals (Revision)Prajwal Regmi, Center for Veterinary Medicine (Division of Food Animal Drugs), 7500 Standish Place, Rockville, MD 20855, 240-402-0577 prajwal.regmi@fda.hhs.gov
Draft GFI #228 – Designing Effectiveness Studies for Drugs Intended to Enhance Animal Production (Growth, Feed Efficiency, Carcass Leanness, Reproduction, Milk Production)Christina Edwards, Center for Veterinary Medicine (HFV-137), 7500 Standish Place, Rockville, MD 20855, 240-402-0824, christina.edwards@fda.hhs.gov
Draft GFI #251 – Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of DiseaseAdam Moyer, Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855, 301-796-2319, adam.moyer@fda.hhs.gov
Draft GFI #256B - Compounding Animal Drugs from Bulk Drug Substances: Compounding in Federally-Registered Facilities that are Subject to CGMPCindy Burnsteel, Center for Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855, 240-402-0817, cindy.burnsteel@fda.hhs.gov
Draft GFI #260 – Type VII Veterinary Master File for Pre-Investigational Development and Research Involving Novel or Rapidly Evolving TechnologiesLynne Boxer, Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855, 240-402-8406, lynne.boxer@fda.hhs.gov
GFI #273 – Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing AnimalsJohn Mussman, Center for Veterinary Medicine (Division of Food Animal Drugs), 7500 Standish Place, Rockville, MD 20855, 240-402-0611, john.mussman@fda.hhs.gov
Draft GFI #277 – Diversion or Reconditioning of Damaged, Contaminated, or Adulterated Food for Use as Animal FoodJennifer Abrahamzon, Center for Veterinary Medicine (HFV-230), 7500 Standish Place, Rockville, MD 20855, 240-402-7382, jennifer.abrahamzon@fda.hhs.gov
GFI #281 – Infectious Otitis Externa Drugs for Topical Use in DogsLea Cranford, Center for Veterinary Medicine (HFV-110), 7500 Standish Place, Rockville, MD 20855, 240-402-0615, lea.cranford@fda.hhs.gov
GFI #282 – Informed Consent Forms for Studies that Enroll Client-Owned Companion AnimalsChrista Johnson, Center for Veterinary Medicine (HFV-112), 7500 Standish Place, Rockville, MD 20855, 240-402-0258, christa.johnson@fda.hhs.gov
Draft GFI #287 – Raw Data for Safety and Effectiveness StudiesLaurie Hanna, Center for Veterinary Medicine (Division of Food Animal Drugs), 7500 Standish Place, Rockville, MD 20855, 240-402-0586, laurie.hanna@fda.hhs.gov
Draft GFI #289 – Use of Zootechnical Substances in Animal FoodKelly Louviere, Center for Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855, 240-402-5815, kelly.louviere@fda.hhs.gov
Draft GFI #291 - Animal Food Intended to Affect the Structure or Function of the AnimalKelly Louviere, Center for Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855, 240-402-5815, kelly.louviere@fda.hhs.gov
Draft GFI #___ - Viable Microorganisms in Animal FoodDiego Paiva, Center for Veterinary Medicine (HFV-229), 7500 Standish Place, Rockville, MD 20855, 240-402-6785, diego.paiva@fda.hhs.gov
Draft GFI #___ – New Chemical Entity Exclusivity for Certain Combination New Animal Drug ProductsDominique Martinez, Center for Veterinary Medicine (HFV-101), 7500 Standish Place, Rockville, MD  20855, 240-402-8989, dominique.martinez@fda.hhs.gov
Draft GFI #___ – Feed-Use Combinations: Recommendations for Satisfying Approval Requirements Under the Animal Drug Availability Act (ADAA)Hilary Hoffman, Center for Veterinary Medicine (HFV-101), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, hilary.hoffman@fda.hhs.gov
Draft GFI #___ – Other Combination New Animal Drugs: Recommendations for Satisfying Approval RequirementsHilary Hoffman, Center for Veterinary Medicine (HFV-101), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, hilary.hoffman@fda.hhs.gov
Draft GFI #___ – Food Ingredients for the Control of Simple Halitosis (Bad Breath) in PetsCiro Ruiz-Feria, Center for Veterinary Medicine (Division of Animal Food Ingredients), 7500 Standish Place, Rockville, MD 20855, 240-402-6282, ciro.ruiz-feria@fda.hhs.gov
Draft GFI #___ – Considerations for Species Grouping in Aquaculture Drug Development for Freshwater-Reared Salmonids and CatfishCassandra Fox, Center for Veterinary Medicine (HFV-170), 7500 Standish Place, Rockville, MD 20855, 240-402-1893, cassandra.fox@fda.hhs.gov
Draft GFI #___ – Predicted Environmental Concentrations (PEC) of Animal Drugs Used in Terrestrial SpeciesAndrew Miglino, Center for Veterinary Medicine (HFV-160), 7500 Standish Place, Rockville, MD 20855, 240-402-1086, andrew.miglino@fda.hhs.gov
Draft GFI #___ – Biomass Drug Substances Amy Simms, Center for Veterinary Medicine (Generic Drug Manufacturing Branch 3), 7500 Standish Place, Rockville, MD 20855, 240-402-0648, amy.simms@fda.hhs.gov
Draft GFI #___ – Post-Approval CMC Changes: New Drug Substance Source and Drug Product Manufacturing SitesAmy Simms, Center for Veterinary Medicine (Generic Drug Manufacturing Branch 3), 7500 Standish Place, Rockville, MD 20855, 240-402-0648, amy.simms@fda.hhs.gov
Draft GFI # ___ - Flea (Ctenocephalides felis) Products for Companion AnimalsJoanna Hoyle, Center for Veterinary Medicine (Division of Companion Animal Drugs), 7500 Standish Place, Rockville, MD 20855, 240-402-0617,
joanna.hoyle@fda.hhs.gov

Compliance Policy Guide (CPG)
(Sub Chapter 600-659 – Veterinary Drugs; Sub Chapter 660-699 – Animal Feed)

Title of CPGContact
Draft CPG Sec. 654.200 – Teat Dips and Udder Washes for Dairy Cows and Goats (Revision)Nick Duckworth, Center for Veterinary Medicine (HFV-214), 7519 Standish Place, Rockville, MD 20855, 240-402-5616, nick.duckworth@fda.hhs.gov

 

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