Resources
Reference materials for animal drug developers.
A curated library of regulatory guidance documents, agency links, and practical references for companies navigating the FDA approval process.
FDA / CVM Resources
FDA Animal Drug Application Process
External linkOverview of the INAD and NADA process, including technical section requirements and the phased review system.
Visit resource →MUMS Drug Designation
External linkFDA guidance on Minor Use and Minor Species drug designations, conditional approval, and the Index of Legally Marketed Unapproved New Animal Drugs.
Visit resource →CVM Guidance Documents
External linkComplete index of FDA/CVM guidance documents covering target animal safety, effectiveness, manufacturing, and labeling requirements.
Visit resource →Pre-submission Meeting Requests
External linkFDA guidance on requesting and preparing for pre-INAD and Type A/B meetings with the Center for Veterinary Medicine.
Visit resource →Regulatory Fundamentals
VICH Guidelines
External linkInternational harmonisation guidelines from the Veterinary International Conference on Harmonisation, covering safety, efficacy, and quality standards accepted by FDA.
Visit resource →Common Technical Document (CTD)
External linkThe internationally harmonised format for regulatory submissions to FDA, including module structure and content requirements.
Visit resource →Good Clinical Practice (GCP) for Veterinary Studies
External linkFDA and VICH guidance on GCP requirements for target animal safety and effectiveness studies.
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