Animal Pharm Reports
North American Animal Health Regulations: 2 Volumes (SR258)
| Published June 2007 |
| | | "In the United States, there are three agencies that regulate animal health. It is important to understand this and to realize that for a non drug product, a different agency in the US may have jurisdiction and, consequently, approval power." | | This report, which has two volumes, is aimed at anyone who needs to understand the basics of animal health regulations in North America. Volume I looks at the legislative framework in place whilst Volume II concentrates on the practical side of submitting an application for market authorization. | | Key coverage | | Market data | | - Take a detailed look at the legislative and regulatory framework in place.
- Understand how to bring an animal drug product to market in the US effectively and efficiently.
- Use Volume 2 of the report as a practical guide taking you through the application processes – with invaluable do’s and don’ts to help make a more favorable impression.
- Find out the procedures for renewals, variations & extensions, generics and good practice guidelines and more – providing you with a one stop resource.
| | For detailed market data and forecasts on the North American Animal Health Market see our recent report World Animal Health Markets. | | | | Key issues | | Learn the roles of the three agencies regulating animal health in the US including, the US Department of Agriculture which regulates animal biological product, the US Environment Protection Agency which regulates pesticide products used on animals and the Food and Drug Administration (FDA) regulates products considered to be animal drugs. Find out the main acts and the FDA regulations as well as guidance on getting approvals and practical tips to speed up the approval process. Volume I of the report looks closely at getting approval for generics products in the US. Volume II guides you carefully through the intricacies of the pre-approval process, as well as the main application and any post-approval requirements. Also included is them process at the Venter for Veterinary Medicine (CVM) for supplemental applications to change or modify the original approved application. | | | | Products and companies covered | | Who should read this report? | | Chapters include:
US Laws, US Pharmacopoeia, FD regulations, FDA guidance documents and guidelines, access to US materials, generic products, regulatory process for generic animal drugs, approval requirements for the ANADA, product variations permitted under the GADPTRA, filing new applications. | | This report will be an ideal guide for:
- Newcomers to the regulatory profession
- Generics manufacturers in or outside of North America
- Or drug developers wanting to market their products in North America. | | | |
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