PS02: Leveraging RWD and Foreign Study Data: Statistical and Regulatory Pathways for Veterinary Drug Approval

The veterinary pharmaceutical industry faces unique challenges in generating robust substantial evidence of effectives for regulatory approval, including limited patient populations for rare conditions, ethical constraints in conducting traditional randomized controlled studies in animals, and significant cost considerations. This session will bring together regulators from FDA-CVM, industry researchers, and academic stakeholders to explore innovative approaches using real-world data (RWD) and foreign study data to generate real-world evidence (RWE) for veterinary drug approval. This interactive panel session will focus on the statistical methodologies and regulatory frameworks that enable the use of alternative evidence sources in veterinary medicine. Participants will gain insights into current FDA-CVM policies, international harmonization efforts, and practical implementation strategies for leveraging external data sources.