North American Animal Health Regulations (2 Volumes)

SUMMARY

"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 tou 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 findings

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.

TABLE OF CONTENTS

CHAPTER 1 US LAWS

• 1.1 The laws
  • 1.1.1 The Food, Drug, and Cosmetic Act of 1938
  • 1.1.2 The Administrative Procedures Act of 1946
  • 1.1.3 Generic Animal Drug and Patent Term Restoration Act of 1988
  • 1.1.4 Animal Medicinal Drug Use Clarification Act of 1994
  • 1.1.5 Animal Drug Availability Act of 1996
  • 1.1.6 The Food and Drug Administration Modernization Act of 1997
  • 1.1.7 Animal Drug User Fee Act of 2002
  • 1.1.8 Minor Use and Minor Species Animal Health Act of 2004
• 1.2 US Pharmacopoeia

CHAPTER 2 FDA REGULATIONS

• 2.1 Title 21 Code of Federal Regulations Part 25 (21 CFR 25)
• 2.2 Title 21 Code of Federal Regulations Part 58 (21 CFR 58)
• 2.3 Title 21 Code of Federal Regulations Part 210 (21 CFR 210)
• 2.4 Title 21 Code of Federal Regulations Part 500 (21 CFR 500)

CHAPTER 3 FDA GUIDANCE DOCUMENTS AND GUIDELINES

CHAPTER 4 ACCESS TO US MATERIALS

• 4.1 FOI Summaries
• 4.2 The laws
• 4.3 The regulations
• 4.4 Guidance documents
• 4.5 Concluding remarks

CHAPTER 5 GENERIC PRODUCTS

• 5.1 Background to the legislation
• 5.2 Abbreviated New Drug Applications
• 5.3 Patent term restoration
• 5.4 Provisions for animal drugs

CHAPTER 6 REGULATORY PROCESS FOR GENERIC ANIMAL DRUGS

CHAPTER 7 APPROVAL REQUIREMENTS FOR THE ANADA

CHAPTER 8 PRODUCT VARIATIONS PERMITTED UNDER THE GADPTRA

• 8.1 Suitability Petition
• 8.2 Hybrid Application