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 linkHow to Get a New Animal Drug Approved and First Steps to Get Started.
Visit resource →CVM Guidance Documents
External linkComplete index of FDA/CVM guidance documents covering target animal safety, effectiveness, manufacturing, and labeling requirements.
Visit resource →FDA’s Role in Veterinary Regenerative Medicine
External linkFDA information on the regulation of cell and tissue products for animals.
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 →Good Clinical Practice (GCP) for Veterinary Studies
External linkFDA and VICH guidance on the design and conduct of all clinical studies of veterinary products in the target species.
Visit resource →