chapter 1 Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act / chapter 2 The New Drug-Approval Process�Before and After 1962 -- chapter 3 FDA Regulation of Biological Products / chapter 4 Generic Drug Approval Process: Pre-1984 History Concerning Generic Drugs / chapter 5 Generic Drug Approval Process, Post-1984: Hatch-Waxman Reform / chapter 6 Food and Drug Administration Modernization Act / chapter 7 FDA Antibiotic Regulatory Scheme: Then and Now / chapter 8 Pioneer and Generic Drugs: Balance Between Product Life Cycle Extension and Anticompetitive Behavior / chapter 9 The Influence of the Prescription Drug User Fee Act on the Approval Process / chapter 10 Clinical Research Requirements for New Drug Applications / chapter 11 Active Pharmaceutical Ingredients / chapter 12 Obtaining Approval of New Drug Applications and Abbreviated New Drug Applications from a Chemistry, Manufacturing, and Controls Perspective / chapter 13 Obtaining Approval of a Generic Drug / chapter 14 Current Good Manufacturing Practice and the Drug Approval Process / chapter 15 CMC Post-approval Regulatory Affairs: Constantly Managing Change / chapter 16 The Influence of the USP on the Drug Approval Process / chapter 17 Ways and Means to U.S. Registration of Foreign Drugs and David Skarinsky / chapter 18 Common Technical Document�Quality (M4-Q): One Regulatory Participant's Perspective / chapter 19 21 CFR Part 11 Compliance and Beyond / chapter 20 Marketing and Advertising/Promotion: The Impact of Government Regulations / chapter 21 Approval and Marketing of Nonprescription or OTC Human Drugs