The Veterinary Drug Approval Process and FDA Regulatory Oversight

The Veterinary Drug Approval Process and FDA Regulatory Oversight seminar provide attendees with an understanding of FDA’s veterinary drug approval process.

Topics

• How FDAs Center for Veterinary Medicine (CVM) is organized
• How the U.S. Food and Drug Administration (FDA) regulates veterinary drug products
• How to open an INAD File and request fee waivers
• The process by which veterinary drug products are reviewed and approved
• A deep understanding of what data is needed to support product characterization, target safety and effectiveness
• A working knowledge of various sections included within a New Animal Drug Application (NADA)
• The various components of an animal field study to support product approval
• General understanding of FDAs rules governing chemistry, manufacturing and controls (CMC)
• The elements of an FDA compliant label
• The difference between FDAs various user fees and fee waivers
• How animal feed, veterinary devices, OTC drug products and nutritional supplements are regulated in the U.S
• The Veterinary Drug Approval Process and FDA Regulatory Oversight brings together:

• Quality professionals
• Senior quality managers
• Compliance professionals
• Regulatory professionals
• Manufacturing engineers
• Production supervisors
• Design engineers
• Production engineers
• Contract Manufacturers
• Labelers and Private Labelers
• U.S. Agents of Foreign Corporations
• Importers and Custom Agents
• Quality engineers
• Process owners
• Document control specialists
• Quality auditors
• Medical affairs
• Record retention specialists
• Financial Advisors and Institutional Investors
• Legal Professionals
• Consultants, Inspectors and cGMP Experts