1.

Record Nr.

UNINA9910459384503321

Autore

Carpenter Daniel P. <1967->

Titolo

Reputation and power organizational image and pharmaceutical regulation at the FDA [[electronic resource] /] / Daniel Carpenter

Pubbl/distr/stampa

Princeton, : Princeton University Press, c2010

ISBN

1-282-63948-X

9786612639487

1-4008-3511-9

Edizione

[Course Book]

Descrizione fisica

1 online resource (825 p.)

Collana

Princeton studies in American politics

Disciplina

362.17/82

Soggetti

Pharmaceutical policy - United States

Drugs - Research - United States

Electronic books.

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

Cover; CONTENTS; LIST OF ILLUSTRATIONS; LIST OF TABLES; ACKNOWLEDGMENTS; LIST OF ABBREVIATIONS AND ACRONYMS; INTRODUCTION: The Gatekeeper; CHAPTER ONE: Reputation and Regulatory Power; PART ONE: ORGANIZATIONAL EMPOWERMENT AND CHALLENGE; CHAPTER TWO: Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath; CHAPTER THREE: The Ambiguous Emergence of American Pharmaceutical Regulation, 1944-1961; CHAPTER FOUR: Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961-1966

CHAPTER FIVE: Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963-1986CHAPTER SIX: Reputation and Power Contested: Emboldened Audiences in Cancer and AIDS, 1977-1992; PART TWO: PHARMACEUTICAL REGULATION AND ITS AUDIENCES; CHAPTER SEVEN: Reputation and the Organizational Politics of New Drug Review; CHAPTER EIGHT: The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite; CHAPTER NINE: The Other Side of the Gate: Reputation, Power, and



Post-Market Regulation

CHAPTER TEN: The DeĢtente of Firm and RegulatorCHAPTER ELEVEN: American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies; CHAPTER TWELVE: Conclusion: A Reputation in Relief; PRIMARY SOURCES AND ARCHIVAL COLLECTIONS; INDEX

Sommario/riassunto

The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints.   Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to re