Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1762
Book Description
Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 38
Book Description
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 38
Book Description
Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1762
Book Description
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1762
Book Description
Notices of Judgement Under the Federal Food, Drug, and Cosmetic Act ...
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Food law and legislation
Languages : en
Pages : 1808
Book Description
Publisher:
ISBN:
Category : Food law and legislation
Languages : en
Pages : 1808
Book Description
Dietary Supplements
Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32
Book Description
Publisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32
Book Description
Definitions and Standards for Food
Author:
Publisher:
ISBN:
Category : Food law and legislation
Languages : en
Pages : 116
Book Description
Publisher:
ISBN:
Category : Food law and legislation
Languages : en
Pages : 116
Book Description
Catalogue of the Public Documents of the ... Congress and of All Departments of the Government of the United States for the Period from ... to ...
Author: United States. Superintendent of Documents
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 2868
Book Description
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 2868
Book Description
Medical Devices and the Public's Health
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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.
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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.
Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act. Drugs and Devices
Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category :
Languages : en
Pages : 1386
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 1386
Book Description
Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309184134
Category : Medical
Languages : en
Pages : 158
Book Description
The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
Publisher: National Academies Press
ISBN: 0309184134
Category : Medical
Languages : en
Pages : 158
Book Description
The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
Catalogue of the Public Documents of the [the Fifty-third] Congress [to the 76th Congress] and of All Departments of the Government of the United States
Author: United States. Superintendent of Documents
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 2636
Book Description
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 2636
Book Description