Oversight, the Food and Drug Administration's Process for Approving New Drugs PDF Download
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Author: United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1324
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Book Description
Author: United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1324
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Book Description
Author: United States. Congress
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 1324
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Book Description
Author: United States. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 688
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Book Description
Author: United States. Congress. Senate. Committee on Human Resources. Subcommittee on Health and Scientific Research
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1668
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Book Description
Author: United States. Congress. Senate. Committee on Human Resources
Publisher:
ISBN:
Category : Human capital
Languages : en
Pages : 1674
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Book Description
Author: Christian Tschanz
Publisher: CRC Press
ISBN: 1040284639
Category : Technology & Engineering
Languages : en
Pages : 322
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Book Description
This useful book reviews and analyzes the rigorous scientific, regulatory, and clinical testing and evaluation applied to the widely used food additive aspartame. In one compact volume you gain access to extensive information illustrating the increased recognition by regulatory agencies of the usefulness of human studies in evaluating new food additives. The Clinical Evaluation of a Food Additive: Assessment of Aspartame begins by describing the nuts and bolts of food additive safety evaluation in humans, including an insightful historical perspective of the development of good clinical practice guidelines. It provides the regulatory requirements for human research, as well as key elements for the design and conduct of human studies. The scientific and regulatory considerations of food additive safety are explored, including interesting descriptions of aspartame's key animal safety studies. In addition, the book reviews the medical postmarketing surveillance system developed for identifying and evaluating reports of aspartame's alleged adverse health effects. Through meticulous research and systematic clarity, The Clinical Evaluation of a Food Additive: Assessment of Aspartame provides work-saving, state-of-the-art examples to guide future testing and evaluation of tomorrow's food additives.
Author: Diana Barbara Dutton
Publisher: Cambridge University Press
ISBN: 9780521395571
Category : Medical
Languages : en
Pages : 548
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Book Description
The distance between medical and public priorities is exposed in four case studies that reveal the human choices governing scientific innnovation and explore the political, economic and social factors influencing those choices.
Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1174
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Book Description
First multi-year cumulation covers six years: 1965-70.
Author: Daniel Carpenter
Publisher: Princeton University Press
ISBN: 1400835119
Category : Political Science
Languages : en
Pages : 825
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Book Description
How the FDA became the world's most powerful regulatory agency 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.
Author: United States. Congress. Senate. Committee on Government Operations
Publisher:
ISBN:
Category : Independent regulatory commissions
Languages : en
Pages : 2076
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Book Description
