A Legislative History Of The Federal Food Drug And Cosmetic Act And Its Amendments

Download or read book A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments: Text written by and published by . This book was released on 1979 with total page 1106 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments written by United States and published by . This book was released on 1979 with total page 1114 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Download or read book Regulating Pesticides in Food written by National Research Council and published by National Academies Press. This book was released on 1987-02-01 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Concern about health effects from exposure to pesticides in foods is growing as scientists learn more about the toxic properties of pesticides. The Delaney Clause, a provision of the Food, Drug and Cosmetic Act, prohibits tolerances for any pesticide that causes cancer in test animals or in humans if the pesticide concentrates in processed food or feeds. This volume examines the impacts of the Delaney Clause on agricultural innovation and on the public's dietary exposure to potentially carcinogenic pesticide residues. Four regulatory scenarios are described to illustrate the effects of varying approaches to managing oncogenic pesticide residues in food.

Download or read book A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments written by and published by . This book was released on 1979 with total page 1042 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments written by United States and published by . This book was released on 1979 with total page 948 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.