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Author: United States. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health
Publisher:
ISBN:
Category : Carcinogens
Languages : en
Pages : 482
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Book Description
Author: United States. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health
Publisher:
ISBN:
Category : Carcinogens
Languages : en
Pages : 482
Get Book Here
Book Description
Author: United States. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health
Publisher:
ISBN:
Category : Carcinogens
Languages : en
Pages : 0
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Book Description
Author: United States. Congress. Senate. Committee on Labor and Public Welfare
Publisher:
ISBN:
Category :
Languages : en
Pages : 200
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Book Description
Author: United States. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health
Publisher:
ISBN:
Category : Carcinogens
Languages : en
Pages : 424
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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 : 1340
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309048370
Category : Medical
Languages : en
Pages : 239
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Book Description
Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
![Preclinical and Clinical Testing by the Pharmaceutical Industry, 1975[-1976] PDF](https://books.google.com/books/content/images/frontcover/VRCMH0FwRvwC?fife=w80-h100)
Author: United States. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 490
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212456
Category : Medical
Languages : en
Pages : 318
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Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category :
Languages : en
Pages : 529
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Book Description
Author: United States. Superintendent of Documents
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1092
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Book Description
February issue includes Appendix entitled Directory of United States Government periodicals and subscription publications; September issue includes List of depository libraries; June and December issues include semiannual index
