Back to: FDA Second Annual Animal Drug User Fee Educational Conference – July 2025
Lesson Content:
Opening Remarks
Walt Ellenberg, Moderator
Special Advisor
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Welcome
Matt Lucia
Director
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Meeting Overview
Walt Ellenberg
Special Advisor
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Overview of User Fees and Waivers
Aila Albrecht
Office of New Animal Product Evaluation
Center for Veterinary Medicine, FDA
Jason Smith
Office of New Animal Product Evaluation
Center for Veterinary Medicine, FDA
Foreign Data
Ana Lazo
Quality Assurance Specialist
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Courtney Flick
Office of New Animal Product Evaluation
Center for Veterinary Medicine, FDA
Brandi Robinson
International Program Manager
Office of New Animal Product Evaluation
Center for Veterinary Medicine, FDA
Abstract
This webinar explores the US Food and Drug Administration’s (FDA) acceptance of foreign data in new animal drug approvals, emphasizing its role in supporting global approvals and minimizing duplicative studies. Foreign data, defined as information generated in studies conducted outside the United States, is acceptable for various technical sections, including target animal safety, effectiveness, and human food safety, helping to bridge gaps in US data. Key expectations for foreign data submissions include ensuring the same data quality and study integrity standards as domestic studies, proactive and early communication with CVM regarding study design and protocols, and a clear explanation of any deviations from US GLP regulations, along with an assessment of their impact. Common challenges encountered during review involve non-compliance with US GLP standards, issues with data measurement units, privacy concerns, inadequate personnel training documentation, and incomplete or inaccurate English translations of study records. To enhance the likelihood of foreign data acceptance, sponsors are encouraged to present data within the context of US approval, submit study protocols for CVM review, and actively engage in international collaboration programs. These collaborative opportunities, such as simultaneous reviews or parallel scientific advice, supported by international harmonization efforts and confidentiality agreements, proactively help ensure foreign studies can fulfill pivotal data requirements for FDA approval.