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
Table of Contents
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.
IRA R. BERRY is President and Founder of International Regulatory Business Consultants, L.L.C., Freehold, New Jersey, USA. Ira Berry received his M.A. in Biology from Hofstra University, Hempstead, New York, USA and his M.B.A. in Management from Adelphi University, Garden City, New York, USA. He has created a consulting business with his extensive experience in the global areas of pharmaceutical manufacturing operations, quality systems, compliance, regulatory affairs and business development—for APIs and dosage forms. He provides instructions and conducts plant audits for CGMP compliance, quality systems evaluation, SOPs, preparing and filing Drug Master Files and dosage form product registrations and personnel training. His professional affiliations include his membership in the Generic Pharmaceutical Association and International Generic Pharmaceutical Association. Berry has worked extensively with Development and Task Force committees with the FDA and is a recognized health care manufacturing industry expert. He was Co-editor of Informa Healthcare’s first edition of The Pharmaceutical Regulatory Process, as well as the titles Pharmaceutical Process Validation and Validation of Active Pharmaceutical Ingredients. Berry also contributed to several chapters in the Encyclopedia of Pharmaceutical Technology.
ROBERT P. MARTIN is a consultant at RPMartin Consulting, Lebanon, Pennsylvania, USA. Dr. Martin received both his M.S. and Ph.D degrees from the University of California, Riverside, California, USA. Throughout his career, he has held positions at many pharmaceutical companies, including Forest Laboratories (as Associate Director of Quality Assurance), Duramed Pharmaceuticals (as Director of Quality Services), Merck & Co. (as Senior Scientist), and Johnson & Johnson (in several positions, including Manager of Quality Services). In these positions, he led efforts to improve performance in Research and Development by developing and implementing compliance and quality systems. At his consulting firm, he currently provides an array of pharmaceutical consulting services, including, such as vendor risk analysis and management, bioanalytical and analytical laboratory qualification/validation, manufacturing qualification/validation, auditing, documentation, CMC preparation, DMF preparation, and training.