Contents

Chapters in this book

1. Frontmatter i
2. Contents vii
3. List of Illustrations ix
4. List of Tables xi
5. Acknowledgments xiii
6. List of Abbreviations and Acronyms xvii
7. Introduction. The Gatekeeper 1
8. Chapter One. Reputation and Regulatory Power 33
9. Part One: Organizational Empowerment and Challenge
10. Chapter Two. Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath 73
11. Chapter Three. The Ambiguous Emergence of American Pharmaceutical Regulation, 1944–1961 118
12. Chapter Four. Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961–1966 228
13. Chapter Five. Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963–1986 298
14. Chapter Six. Reputation and Power Contested: Emboldened Audiences in Cancer and Aids, 1977–1992 393
15. Part Two: Pharmaceutical Regulation and Its Audiences
16. Chapter Seven. Reputation and the Organizational Politics of New Drug Review 465
17. Chapter Eight. The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite 544
18. Chapter Nine. The Other Side of the Gate: Reputation, Power, and Post-Market Regulation 585
19. Chapter Ten. The Détente of Firm and Regulator 635
20. Chapter Eleven. American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies 686
21. Chapter Twelve. Conclusion: A Reputation in Relief 727
22. Primary Sources and Archival Collections 753
23. Index 759