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
- Pharmaceutical Regulation Before and After the Food, Drug,
and Cosmetic Act
- Modernizing the Food and Drug Administration
- The New Drug–Approval Process—Before and After 1962
- Generic Drug-Approval Process: Hatch–Waxman Update
- FDA Regulation of Biological Products
- FDA’s Antibiotic Regulatory Scheme: Then and Now
- Generic Drugs in a Changing Intellectual Property Landscape
- The Influence of the Prescription Drug User Fee Act on the Approval
Process
- Clinical Research Requirements for New Drug Applications
- PostapprovalMarketing Practices Regarding Drug Safety and
Pharmacovigilance
- DrugsMarketedWithout FDA Approval
- FDA Regulation of Foreign Drug Imports: The Need for Improvement
Part II: Regulatory Requirements for Product Approvals and After
- Active Pharmaceutical Ingredients
- Obtaining Approval of New Drug Applications and Abbreviated New
Drug Applications from a Chemistry, Manufacturing, and Controls
Perspective
- Obtaining Approval of a Generic Drug, Pre-1984 to the Present
- New Developments in the Approval and Marketing of Nonprescription or
OTC Drugs
- Current Good Manufacturing Practice and the Drug Approval Process
- The Influence of the USP on the Drug Approval Process
- Ways,Means, and Evolving Trends in the U.S. Registration of Drug
Products from Foreign Countries
- Impact of Government Regulation on Prescription Drug Marketing and
Promotion
- CMC Postapproval Regulatory Affairs: Constantly Managing Change
- Living with 21 CFR Part 11 Compliance
Index