A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments: Text PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments: Text PDF full book. Access full book title A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments: Text by . Download full books in PDF and EPUB format.
Author:
Publisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 1106
Get Book Here
Book Description
Author:
Publisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 1106
Get Book Here
Book Description
Author:
Publisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 1076
Get Book Here
Book Description
Author:
Publisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 1418
Get Book Here
Book Description
Author: United States
Publisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 1566
Get Book Here
Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
Get Book Here
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
Publisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 1114
Get Book Here
Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309184134
Category : Medical
Languages : en
Pages : 158
Get Book Here
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.
Author: Stuart Chase
Publisher: New York : Macmillan
ISBN:
Category : Commercial crimes
Languages : en
Pages : 304
Get Book Here
Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309048370
Category : Medical
Languages : en
Pages : 239
Get Book Here
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.
Author:
Publisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 1068
Get Book Here
Book Description
