New Drug Development A Regulatory Overview

This new Fourth Edition chronicles and analyzes the factors that now drive the FDA's regulatory processes. It explains the CDER restructuring, FDA-initiated reforms, affecting Phase 1 studies moving from the US to Europe, how FDA has downscaled its IND submission requirements, and much more.

Contents include:

• An Introduction to the US New Drug Approval Process
  
• Nonclinical Drug Testing
  
• The FDA's Regulation of Nonclinical Testing: Good Laboratory Practice (GLP)
  
• The Investigational New Drug Application (IND)
  
• CDER and the IND Review Process
  
• The Clinical Development of New Drugs
  
• Good Clinical Practices (GCP)
  
• The New Drug Application (NDA)
  
• The NDA Review Process
  
• The FDA's Drug Classification System
  
• Advisory Committees and the Drug Approval Process
  
• Beyond Approval: Drug Manufacturer Regulatory Responsibilities
  
• The Supplemental NDA and Postapproval Changes to Marketed Drugs
  
• The FDA's Orphan Drug Development Program
  
• CDER's Bioresearch Monitoring Program
  
• Accelerated Drug Approval/Accessability Programs

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