The pharmaceutical regulatory process / edited by Ira R. Berry.

Includes bibliographical references and index.

Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act. New Drug Approval Process: Before and After 1962. FDA Regulation of Biological Products. Generic Drug Approval Process: Pre-1984 History Concerning Generic Drugs. Generic Drug Approval Process: Post 1984: Waxman-Hatch Reform. Food and Drug Administration Modernization Act. FDA's Antibiotic Regulatory Scheme: Then and Now. Pioneer and Generic Drugs: 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. Active Pharmaceutical Ingredients. Obtaining Approval of a New Drug . Obtaining Approval of a Generic Drug. Current Good Manufacturing Practice and the Drug Approval Process. CMC Post-Approval Regulatory Affairs: Constantly Managing Change. The Influence of the USP on the Drug Approval Process. Ways and Means to U.S. Registration of Foreign Drugs. Common Technical Document-Quality (M4-Q): One Regulatory Participant's Perspective. 21 CFR Part 11: Compliance and Beyond. Marketing and Advertising Promotion: The Impact of Government Regulations. Approval and Marketing of Nonprescription or OTC Human Drugs.

"Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States - standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality issues influencing the pharmaceutical industry."--book jacket.