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
Preface. Contributors. PART I LEGAL REQUIREMENTS FOR REGULATORY COMPLIANCE. 1. Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act. 2. Modernizing the Food and Drug Administration. 3. The New Drug-Approval Process-Before and After 1962. 4. Generic Drug-Approval Process: Hatch-Waxman Update. 5. FDA Regulation of Biological Products. 6. FDA's Antibiotic Regulatory Scheme: Then and Now. 7. Generic Drugs in a Changing Intellectual Property Landscape. 8. The Influence of the Prescription Drug User Fee Act on the Approval Process. 9. Clinical Research Requirements for New Drug Applications. 10. Postapproval Marketing Practices Regarding Drug Safety and Pharmacovigilance. 11. Drugs Marketed Without FDA Approval. 12. FDA Regulation of Foreign Drug Imports: The Need for Improvement. PART II REGULATORY REQUIREMENTS FOR PRODUCT APPROVALS AND AFTER. 13. Active Pharmaceutical Ingredients. 14. Obtaining Approval of New Drug Applications and Abbreviated New Drug Applications from a Chemistry, Manufacturing, and Controls Perspective. 15. Obtaining Approval of a Generic Drug, Pre-1984 to the Present. 16. New Developments in the Approval and Marketing of Nonprescription or OTC Drugs. 17. Current Good Manufacturing Practice and the Drug Approval Process. 18. The Influence of the USP on the Drug Approval Process. 19. Ways,Means, and Evolving Trends in the U.S. Registration of Drug Products from Foreign Countries. 20. Impact of Government Regulation on Prescription Drug Marketing and Promotion. 21. CMC Postapproval Regulatory Affairs: Constantly Managing Change. 22. Living with 21 CFR Part 11 Compliance. Index.
