Council On Competitiveness And Fda Plans To Alter The Drug Approval Process At Fda

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Genre : Medical
Author : United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee
Publisher :
Release : 1993
File : 364 Pages
ISBN-13 : PURD:32754075429328


The Semi Sovereign Presidency

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In The Semi-Sovereign Presidency, Capitol Hill insider Charles Tiefer shows how George Bush used the executive office to circumvent Congress, thwart official Washington, and confound the public will. Even Bush partisans may be surprised to discover the president's unprecedented use of executive signing statements to modify or, in effect, abrogate acts of Congress—even popular, bipartisan efforts like the 1991 Civil Rights Act; his commissioning of the "Quayle Council" to derail regulatory legislation such as the Clean Air Act of 1990; and his catapulting of the National Security Council into foreign policy prominence outstripping that of the Departments of Defense and State. As Tiefer details for the first time here, "Iraqgate," the hidden courtship of Saddam Hussein prior to the Gulf War, is perhaps the most dramatic example of Bush's executive fiat—a relationship conducted by way of Bush National Security Directives and similarly obscured from the public eye. Bush chose an essentially negative approach to governing partly because he was unwilling to engage Congress on matters of principle head to head and was equally unwilling to make his principles public—addressing himself to the nation as his predecessor had so effectively done. But, as Tiefer persuasively argues, it was Bush's belief in the sovereignty of executive power—an almost monarchical conception of the presidency—that was his primary modus operandi and ultimately his downfall. Bush and his approach to power are interesting not just to students and scholars of the presidency but to all citizens concerned about the country and its leadership.

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Genre : Political Science
Author : Charles Tiefer
Publisher : Routledge
Release : 2019-07-11
File : 186 Pages
ISBN-13 : 9781000305425


Monthly Catalogue United States Public Documents

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Genre : Government publications
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Release : 1993-07
File : 868 Pages
ISBN-13 : UIUC:30112063914649


Monthly Catalog Of United States Government Publications

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Genre : Government publications
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Release : 1993
File : 872 Pages
ISBN-13 : OSU:32435032754814


The Risks Of Medical Innovation

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Presenting a new way of thinking about the risks of medical innovation, this volume considers the issues from a social historical perspective, and studies specific cases in their respective contexts.

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Genre : Biomedical Technology
Author : Thomas Schlich
Publisher : Psychology Press
Release : 2006
File : 328 Pages
ISBN-13 : 0415334810


Legislative Reorganization Act Of 1994

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Genre : Budget
Author : United States. Congress. House. Committee on Rules. Subcommittee on the Legislative Process
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Release : 1994
File : 564 Pages
ISBN-13 : IND:30000091119366


Deadly Medicine

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"Deadly Medicine tells the dramatic story of a great tragedy involving a class of drugs still on the market. It reveals why the same medical system that brings us lifesaving treatments can create a catastrophe almost beyond imagining." "The story begins with a new heart drug created in the research laboratories of the 3M Company. In animals, this drug appears unusually effective in suppressing irregular heartbeats. Hoping for a blockbuster, 3M launches clinical tests in humans and plans how to seize the market from competing companies. But as medical researchers test Tambocor, as the drug is called, the first signs of potential trouble appear. At Stanford University, a doctor warns that this type of powerful drug may be dangerous. Other experiments fail to demonstrate the expected benefits of such drugs. But with the support of their clinical doctors and with millions of dollars invested in Tambocor, 3M moves ahead and seeks approval from the FDA. Other companies also follow suit with similar drugs." "Questions about the safety of Tambocor have already reached the medical review staff at the FDA in Washington, D.C., where a behind-the-scenes drama takes place. 3M presses for approval of Tambocor, while the FDA staff tries to interpret the meaning of reports that some patients who have taken the drug suddenly drop dead. Without a green light from the FDA, Tambocor may be doomed." "The final chapters in the story unfold as 3M gets to the marketplace and, using all the skills of a modern pharmaceutical manufacturer, persuades doctors to use Tambocor. At the same time, an important clinical trial begins. The National Institutes of Health launch an experiment with more than a thousand patients to measure the benefits of Tambocor and two similar drugs. The shocking results of that study and the response of the doctors and companies who promoted these drugs bring the tragedy to a powerful conclusion." "Deadly Medicine is a human story about the brilliant and driven doctors who worked on Tambocor and similar heart drugs - at pharmaceutical companies, within the FDA, and at university medical research centers. It provides a vivid and disturbing account of the system by which drugs are discovered, tested, and marketed to doctors. Through the tragic story of how tens of thousands of patients died prematurely from one class of heart drugs, Deadly Medicine also exposes major flaws in this system."--BOOK JACKET.Title Summary field provided by Blackwell North America, Inc. All Rights Reserved

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Genre : Current Events
Author : Thomas J. Moore
Publisher :
Release : 1995
File : 360 Pages
ISBN-13 : STANFORD:36105009829008


Sociology

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Genre : Sociology
Author :
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Release : 1998
File : 952 Pages
ISBN-13 : UCAL:B4927888


Minnesota Law Review

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Genre : Electronic journals
Author :
Publisher :
Release : 1998
File : 1188 Pages
ISBN-13 : UFL:30031002278462


Cis Annual

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Genre : Government publications
Author :
Publisher :
Release : 2005
File : 688 Pages
ISBN-13 : OSU:32437122349331