Back to: FDA First Annual Animal Drug User Fee Educational Conference – July 2024
Lesson Content:
Human Food Safety Technical Section Overview
Kimon Kanelakis
Toxicology Team
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Jonathan Greene
Biologist
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Heather Harbottle
Senior Regulatory Microbiologist
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Environmental Impact Technical Section Overview
Holly Zahner
Supervisory Toxicologist
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Minor Technical Sections All Other Information, and Freedom of Information Summary, Labeling
Ann Stohlman
Veterinary Medical Officer
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Suzanne Sechen
Growth, Endocrinology, and Metabolism Team
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Q&A Session on Technical Sections
Walt Ellenberg & CVM Panel
Closing Remarks
Walt Ellenberg
Special Advisor
Office of New Animal Drug Evaluation
Center for Veterinary Medicine, FDA
Abstract
This webinar, the first annual Animal Drug User Fee Educational Conference, provides a foundational understanding of the new animal drug approval process by the US Food and Drug Administration’s Center for Veterinary Medicine. It details the comprehensive pre-market review, ensuring drugs are safe and effective for animals and that food derived from treated animals is safe for human consumption. Key discussions cover the US Food and Drug Administration’s program for real world data and real world evidence, which supports new animal drug approvals by analyzing routinely collected data. The conference introduces adaptive study designs, offering resource and ethical benefits by allowing planned modifications based on accumulating study data. Emphasis is placed on submitting high-quality information, ensuring clear organization, consistency, and the provision of credible raw data adhering to ALCOA principles. The human food safety technical section is explored, detailing how toxicology, residue chemistry, and antimicrobial resistance components ensure drug residues in edible tissues are safe for human consumption, establishing acceptable daily intakes, tolerances, and withdrawal periods. The environmental impact technical section evaluates potential environmental effects from drug use and disposal under the National Environmental Policy Act, guiding sponsors on categorical exclusions or environmental assessments. Minor technical sections, including all other information, freedom of information summaries, and detailed labeling requirements for drugs and medicated articles/feeds, are also explained. The presentation consistently stresses the importance of early and continuous communication with CVM project managers to streamline review timelines and facilitate the approval of safe and effective animal drugs.