The Pharmaceutical Regulatory Process, Second Edition

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.

New chapters cover:

• the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
• pharmacovigilance programs designed to prevent widespread safety issues
• legal issues surrounding the sourcing of foreign APIs
• the issues of counterfeit drugs
• updates on quality standards

Legal requirements for regulatory compliance

• Post-Approval Marketing Practices Regarding Drug Safety and Pharmacovigilance
• Marketing Unapproved New Drugs
• Legal Issues Surrounding the Importation of Foreign APIs
• Generic Drug Approval Process and Movement to Reform
• The Food and Drug Administration Modernization Act û FDAMA and Beyond
• FDAÆs Antibiotic Regulatory Scheme
• Pioneer and Generic Drugs: New Developments in Balance Between Product Life Cycle Extension and Anti-Competitive Behavior
• The Influence of the Prescription Drug User Fee Act on the Approval Process
• Clinical Research Requirements for New Drug Applications

  
  
  Regulatory Requirements for Product Approvals and After

  
  
   
• Active Pharmaceutical Ingredients
   
• Update on Quality Standards
• Obtaining Approval of a New Drug: Industry Perspective
• Obtaining Approval of a Generic Drug: Industry Perspective
• New Developments in the Approval and Marketing of Nonprescription or OTC Drugs
• Current Good Manufacturing Process and the Drug Approval Process
• The Influence of the USP on the Drug Approval Process
• Evolving Trends in U.S. Registration and Importation of Drug Products from Foreign Countries
• Marketing and Advertising Promotion: The Impact of Government Regulations
• CMC Post-Approval Regulatory Affairs: Constantly Managing Change
• CFR Part 11: Compliance and Beyond