The Pharmaceutical Regulatory Process
Second edition
edited by Ira R. Berry

The Pharmaceutical Regulatory Process 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, the bookincludes 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

Contents

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. PostapprovalMarketing Practices Regarding Drug Safety and Pharmacovigilance
11. DrugsMarketedWithout 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

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