Rajashree Patil, Chandrakant Galdhar

Animal healthcare is a booming market catering needs of several companion and production purpose animals. Animal drug approval process in the United States (US) involves submission of an Investigational New Animal Drug Application (INAD), followed by submission of New Animal Drug Application (NADA) to the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM). Although regional variations are present in the regulatory process for veterinary healthcare products across the globe, harmonization initiatives like International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) are playing a vital role in the veterinary medicinal product registration process by availing detailed guidance documents. The current article focuses on the regulatory requirements for new animal drug registration in the US.