Front Cover -- Title Page -- Half Tilte -- Copyright -- Dedication -- Contents -- List of Figures -- Foreword - Terry L. Anderson -- Preface - John J. Cohrssen -- Acknowledgments -- Introduction -- Part I: The Need for Fundamental Food and Drug Administration Reform -- Chapter 1: The Birth and Growth of Premarket Regulation -- Chapter 2: Factors Affecting Drug Development -- Chapter 3: Reforming the Current System -- Chapter 4: The Failure of Self-Reform and Congressional Reform -- Part II: A Model for Reform of the Food and Drug Administration -- Chapter 5: A Spectrum of Possibilities -- Chapter 6: A Proposal for Regulatory Reform -- Summary -- Index.