Description

Navigating New Animal Drug Applications (NADA): The Path to Animal Drug Approvals offers a comprehensive guide to the intricate process of getting veterinary drugs approved through the FDA's Center for Veterinary Medicine (CVM). This book demystifies the regulatory framework, providing detailed insights into the preparation, submission, and approval of animal drug applications. From preclinical safety studies and clinical trial design to post-approval monitoring, it covers every critical phase of the NADA process. With a focus on practical strategies, it helps pharmaceutical companies, veterinarians, and researchers streamline their applications and avoid common pitfalls. Additionally, the book explores emerging trends, such as biologics and antimicrobial resistance, ensuring readers stay ahead in the evolving landscape of veterinary medicine.