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Regulatory Framework for Approval of New Animal Drugs in United States


 
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1. Title Title of document Regulatory Framework for Approval of New Animal Drugs in United States
 
2. Creator Author's name, affiliation, country Rajashree Patil; Domain Consultant, Veterinary Writing, Tata Consultancy Services, Pune, India
 
2. Creator Author's name, affiliation, country Chandrakant Galdhar; Department of Medicine, Bombay Veterinary College, Mumbai, India
 
3. Subject Discipline(s)
 
3. Subject Keyword(s) US FDA; CVM; new animal drug approval; INAD; NADA
 
4. Description Abstract 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.
 
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6. Contributor Sponsor(s)
 
7. Date (YYYY-MM-DD) 2017-02-23
 
8. Type Status & genre Peer-reviewed Article
 
8. Type Type
 
9. Format File format PDF
 
10. Identifier Uniform Resource Identifier http://scientific.cloud-journals.com/index.php/IJAVST/article/view/Sci-534
11. Source Journal/conference title; vol., no. (year) International Journal of Advanced Veterinary Science and Technology; Volume 6 (Year 2017)
 
12. Language English=en en
 
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