Back to: FDA First Annual Animal Drug User Fee Educational Conference – July 2024
Lesson Content:
Communication Pathways with CVM
Annie Roa
Project Manager
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Best Practices in the Approval Process
Ana Lazo
Quality Assurance Specialist
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Delisa Davis
Quality Assurance Specialist
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Q&A on the General Approval Process
Walt Ellenberg & CVM Panel
Abstract
This webinar provides an essential guide to communication pathways and best practices for submitting high-quality information to the US Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) for new animal drug approvals. It outlines initial contact points for new sponsors, including Ask CVM and the project management mailbox, and details the registration process for electronic submission systems like FDA ESG and CVM ESS, emphasizing the use of the eSubmitter tool. The presentation covers formal and informal communication methods, highlighting the significance of the Investigational New Animal Drug (INAD) file as the central record for formal communications throughout the phased review process. Key formal interactions discussed include various meeting types like Presubmission Conferences, where binding agreements on development plans are reached, Method Demonstration meetings, and other ONAD meetings for specific topics. Newer processes like the early response letter for virtual presubmission conferences and the informal written response process (C-submission) for less complex queries are also introduced. A critical focus is placed on the importance of submission quality, stressing clear organization, consistent documentation, adherence to good documentation practices (GDPs), and the submission of credible raw data adhering to ALCOA principles (attributable, legible, contemporaneous, original, accurate). Common submission and study quality gaps observed by CVM are discussed, along with the vital role of Quality Assurance Study Reviewers (Quazars) in ensuring data integrity. Early and continuous communication with CVM project managers is highly encouraged to streamline the approval process and foster shared expectations.