North American Animal Health Regulations (2 Volumes)

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