Research and Markets: North American Animal Health Regulations (2 Volumes)
Posted on: Tuesday, 15 January 2008, 12:00 CST
Research and Markets (http://www.researchandmarkets.com/reports/c79621) has announced the addition of North American Animal Health Regulations (2 Volumes) to their offering.
"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
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.
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.
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.
Who should read this report?
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.
Chapter Outline:
Volume 1
Chapter 1 Us Laws
Chapter 2 FDA Regulations
Chapter 3 FDA Guidance Documents And Guidelines
Chapter 4 Access To Us Materials
Chapter 5 Generic Products
Chapter 6 Regulatory Process For Generic Animal Drugs
Chapter 7 Approval Requirements For The Anada
Chapter 8 Product Variations Permitted Under The Gadptra
Volume 2
Chapter 1 The Compound Is Identified
Chapter 2 Background Package And New Animal Drug Application
Chapter 3 The Pre-Submission Conference
Chapter 4 Protocol Submissions
Chapter 5 Submission Of Data
Chapter 6 Filing New Applications
Chapter 7 Phased Reviews
Chapter 8 Technical Sections
Chapter 9 Review Of The Data
Chapter 10 Approval Of Technical Sections And The New Animal Drug Application
Chapter 11 Post Approval Requirements
Chapter 12 Supplemental Applications
Volume I
In the United States, there are three agencies that regulate animal health products. The US Department of Agriculture regulates animal biological products, the US Environmental Protection Agency regulates pesticide products used on animals and the Food and Drug Administration (FDA) regulates products considered to be animal drugs. It is important to understand this and to realise that for a non-drug product, a different agency in the US may have jurisdiction and, consequently, approval power.
This report comes in two volumes. The first (current) volume takes a detailed look at the legislative and regulatory framework in place. These include the main acts and the FDA regulations. The FDA guidance on getting product approval is also outlined. Practical tips on how to access useful information on the regulatory side are given.
This volume will help you understand how to bring an animal drug product to market in the US. The interactions needed to gain approval for an animal drug, the responsibilities a sponsor has post approval, and how the dossier can be modified to account for needed or desired changes following the initial application will all be explained. This volume also looks closely at getting an approval for generic products in the US.
Also included is the process at the Center for Veterinary Medicine (CVM) for supplemental applications to change or modify the original approved application is described.
Volume II
In the United States, there are three agencies that regulate animal health products. The US Department of Agriculture regulates animal biological products, the US Environmental Protection Agency regulates pesticide products used on animals and the Food and Drug Administration (FDA) regulates products considered to be animal drugs. It is important to understand this and to realise that for a non-drug product, a different agency in the US may have jurisdiction and, consequently, approval power.
This report has two volumes. Volume I looks at the legislative framework in place governing the acquisition of a market approval for a veterinary drug. This tome (Volume II) concentrates on the practical side of submitting an application for a market authorisation.
The approval process is examined from the standpoint of a sponsor starting with a new chemical entity that is believed to have utility for an animal health need. This begins with the identification of a new compound and the development phase. The ensuing description focuses on a linear progression through the regulatory process in achieving approval to market the product in the US.
The current volume explains what the Background Package is and its role in the pre-approval phase. The Background Package details for the Center for Veterinary Medicine reviewers what the sponsor knows about the molecule (chemical data). This includes literature that may exist, the potential claims the sponsor hopes to achieve, a preliminary outline of a plan of development, and even a draft label that the sponsor hopes to obtain. The explanation then moves on to the presubmission conference, where the CVM meets with the sponsor to discuss a development programme.
This part of the two-volume report guides you carefully through the intricacies of the pre-approval process, as well as the main application and any post-approval requirements.
For more information visit http://www.researchandmarkets.com/reports/c79621
Source: Informa Healthcare
Source: Business Wire
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