Organizational Image and Pharmaceutical Regulation at the FDA
Author: Daniel Carpenter
Publisher: Princeton University Press
Category: Political Science
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 regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today. Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested. Some images inside the book are unavailable due to digital copyright restrictions.
Organizational Image and Pharmaceutical Regulation at the FDA
Author: Daniel P. Carpenter
"In this truly splendid, magisterial study, Carpenter thoroughly documents and narrates the FDA's struggle with the certainties of science, the uncertainties of politics, and the requirements of reputation, an asset that simultaneously granted the agency autonomy and then took it away through ever-increasing expectations of performance."--Richard Bensel, Cornell University "Deeply researched and subtly conceived, "Reputation and Power" demonstrates how much our modern system of drug regulation and clinical research owes to the scientific creativity and political skills of federal drug regulators over the past sixty years. It will be the standard work on the FDA for decades to come, while providing instructive lessons for how one can think critically about government regulation without recourse to the ideological lenses of the Left or the Right."--Harry M. Marks, history of medicine, Johns Hopkins University ""Reputation and Power" is by far the most thorough and penetrating study of the most powerful and important regulatory agency in the world--the U.S. Food and Drug Administration--and one of the best studies of any American regulatory agency. The book is essential reading for anyone seriously interested in American politics, public policy, administrative institutions, or health and medicine. This is an extraordinary work."--Paul Quirk, University of British Columbia "Carpenter has integrated an understanding of the FDA's legal history and programmatic responsibilities with a perceptive grasp of the personalities who shaped that history. His work surpasses in depth and scope all other accounts of the FDA with which I am familiar. No one in the future will be able to write seriously about the FDA's drug approval system without taking account of Carpenter's work. His curiosity knows no limits."--Richard A. Merrill, professor emeritus, University of Virginia, former FDA general counsel, and coauthor of "Food and Drug Law: Cases and Materials"
Pharmaceutical sciences, Pharmaceutical sciences
Author: CTI Reviews
Publisher: Cram101 Textbook Reviews
Facts101 is your complete guide to Reputation and Power , Organizational Image and Pharmaceutical Regulation at the FDA. In this book, you will learn topics such as as those in your book plus much more. With key features such as key terms, people and places, Facts101 gives you all the information you need to prepare for your next exam. Our practice tests are specific to the textbook and we have designed tools to make the most of your limited study time.
Author: Edda Weigand,Marcelo Dascal
Publisher: John Benjamins Publishing
Category: Language Arts & Disciplines
The topic of negotiation has turned out to be of crucial interdisciplinary interest for our understanding of what we are doing in language use. Are we exchanging meanings defined in advance and presupposing equal understanding on the basis of a rule-governed system, or are we negotiating meaning and understanding in the framework of an open dialogic universe? Negotiation, on the one hand, can be taken as the name of a specific dialogue type or action game of bargaining. On the other hand, it represents a methodological concept for describing and explaining dialogic interaction which replaces the orthodox view of pattern transference. The papers collected in this volume deal with both versions of the concept of negotiation. This volume contains a selection of papers presented at the International Conference on Pragmatics and Negotiation at Tel Aviv University and the Hebrew University of Jerusalem in June, 1999. The dialogic aspect was taken as the key concept to guide the present selection.
Author: Robert Greene
Publisher: Carl Hanser Verlag GmbH Co KG
Category: Political Science
Mit über 200.000 verkauften Exemplaren dominierte „Power – Die 48 Gesetze der Macht“ von Robert Greene monatelang die Bestsellerlisten. Nun erscheint der Klassiker als Kompaktausgabe: knapp, prägnant, unterhaltsam. Wer Macht haben will, darf sich nicht zu lange mit moralischen Skrupeln aufhalten. Wer glaubt, dass ihn die Mechanismen der Macht nicht interessieren müssten, kann morgen ihr Opfer sein. Wer behauptet, dass Macht auch auf sanftem Weg erreichbar ist, verkennt die Wirklichkeit. Dieses Buch ist der Machiavelli des 21. Jahrhunderts, aber auch eine historische und literarische Fundgrube voller Überraschungen.
Author: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Publisher: National Academies Press
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Authority and Power in Presidential Politics
Author: Nigel Bowles
Publisher: Texas A&M University Press
Category: Biography & Autobiography
Using Richard E. Neustadt's analytical framework of presidential power, Bowles develops five case studies around Nixon's economic policies. These analyses help readers understand the sources of Nixon's authority and power and his use of both, and demonstrate the implications of authority and power for understanding the institution of the presidency.
The Web Spun by Taino Rulers Between Hispaniola and Puerto Rico
Author: José R. Oliver
Publisher: University of Alabama Press
Caciques and Cemi Idolstakes a close look at the relationship between humans and other (non-human) beings that are imbued with cemí power, specifically within the Taíno inter-island cultural sphere encompassing Puerto Rico and Hispaniola.
Publisher: Delphi Classics
Beloved as a writer of exciting biographies and renowned for his philanthropic essays on almost any subject possible, Plutarch created a diverse range of works that have entertained generations of readers since the days of Imperial Rome. Delphi's Ancient Classics series provides eReaders with the wisdom of the Classical world, with both English translations and the original Greek texts. This comprehensive eBook presents the complete works of Plutarch, with beautiful illustrations, informative introductions and the usual Delphi bonus material. (Version 1) * Beautifully illustrated with images relating to Plutarch's life and works * Features the complete works of Plutarch, in both English translation and the original Greek * Concise introductions to the works * Provides the complete PARALLEL LIVES and the complete extant essays of MORALIA, for the first time in digital printing * Includes many translations previously appearing in Loeb Classical Library editions of Plutarch's works * Excellent formatting of the texts * Easily locate the biographies and treatises you want to read with individual contents tables * Features two bonus biographies - discover Plutarch's ancient world * Scholarly ordering of texts into chronological order and literary genres Please visit www.delphiclassics.com to browse through our range of exciting titles CONTENTS: The Translations PARALLEL LIVES MORALIA The Greek Texts LIST OF GREEK TEXTS The Biographies INTRODUCTION TO PLUTARCH by Bernadotte Perrin LIFE OF PLUTARCH by Aubrey Stewart Please visit www.delphiclassics.com to browse through our range of exciting titles
Islam’s First Great General
Author: Richard A. Gabriel
Publisher: University of Oklahoma Press
Category: Biography & Autobiography
That Muhammad succeeded as a prophet is undeniable; a prominent military historian now suggests that he might not have done so had he not also been a great soldier. Best known as the founder of a major religion, Muhammad was also Islam’s first great general. While there have been numerous accounts of Muhammad the Prophet, this is the first military biography of the man. In Muhammad: Islam’s First Great General, Richard A. Gabriel shows us a warrior never before seen in antiquity—a leader of an all-new religious movement who in a single decade fought eight major battles, led eighteen raids, and planned thirty-eight other military operations. Gabriel’s study portrays Muhammad as a revolutionary who introduced military innovations that transformed armies and warfare throughout the Arab world. Gabriel analyzes the environment in which Muhammad lived and the religion he inspired as they relate to his military achievements. Gabriel explains how Muhammad changed the social composition of Arab armies by replacing traditional ways of fighting with a new command structure. Muhammad’s transformation of Arab warfare enabled his successors to establish the core of the Islamic empire—an accomplishment that, Gabriel argues, would have been militarily impossible without Muhammad’s innovations. Richard A. Gabriel challenges existing scholarship on Muhammad’s place in history and offers a viewpoint not previously attempted.
Author: Patrick Little
Publisher: Macmillan International Higher Education
Little integrates the latest research from younger and established scholars to provide a new evaluation and 'biography' of Cromwell. The book challenges received wisdom about Cromwell's rise to power, his political and religious beliefs, his relationship with various communities across the British Isles and his role as Lord Protector.
Books, Literature, and the Culture of Consumption in Germany, 1770–1815
Author: Matt Erlin
Publisher: Cornell University Press
Category: Literary Criticism
The consumer revolution of the eighteenth century brought new and exotic commodities to Europe from abroad—coffee, tea, spices, and new textiles to name a few. Yet one of the most widely distributed luxury commodities in the period was not new at all, and was produced locally: the book. In Necessary Luxuries, Matt Erlin considers books and the culture around books during this period, focusing specifically on Germany where literature, and the fine arts in general, were the subject of soul-searching debates over the legitimacy of luxury in the modern world. Building on recent work done in the fields of consumption studies as well as the New Economic Criticism, Erlin combines intellectual-historical chapters (on luxury as a concept, luxury editions, and concerns about addictive reading) with contextualized close readings of novels by Campe, Wieland, Moritz, Novalis, and Goethe. As he demonstrates, artists in this period were deeply concerned with their status as luxury producers. The rhetorical strategies they developed to justify their activities evolved in dialogue with more general discussions regarding new forms of discretionary consumption. By emphasizing the fragile legitimacy of the fine arts in the period, Necessary Luxuries offers a fresh perspective on the broader trajectory of German literature in the late eighteenth and early nineteenth century, recasting the entire period in terms of a dynamic unity, rather than simply as a series of literary trends and countertrends.
The Realignment of International Relations
Author: Yong Deng
Publisher: Cambridge University Press
Category: Political Science
At the end of the Cold War the People's Republic of China found itself in an international crisis, facing severe problems in both domestic politics and foreign policy. Nearly two decades later, Yong Deng provides an original account of China's remarkable rise from the periphery to the center stage of the post-Cold War world. Deng examines how the once beleaguered country has adapted to, and proactively realigned, the international hierarchy, great-power politics, and its regional and global environment in order to carve out an international path within the globalized world. Creatively engaging with mainstream international relations theories and drawing extensively from original Chinese material, this is a well-grounded assessment of the promises and challenges of China's struggle to manage the interlacing of its domestic and international transitions and the interactive process between its rise and evolving world politics.
Author: Lucy Delap,Maria DiCenzo,Leila Ryan
Publisher: Taylor & Francis
The Edwardian period experienced a particularly vibrant periodical culture, with phenomenal growth in the numbers of titles published that were either aimed specifically at women, or else saw women as a key section of their readership or contributor group. It was an era of political ferment in which a number of 'progressive' traditions were formulated, shaped or abandoned, including socialism, feminism, modernism, empire politics, trade unionism and welfarism. Organized around some of the central themes of political thought and utopian thinking, this impressive collection gathers together classic articles from key periodicals. The set presents a comprehensive sourcebook of readings on Edwardian/Progressive era feminist thought, exploring the intervention of the radical public intellectuals working in these traditions in North America and the UK from 1900-1918.