Adequacy of FDA to Assure the Safety of the Nation’s Drug Supply: Congressional Hearing 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 Adequacy of FDA to Assure the Safety of the Nation’s Drug Supply: Congressional Hearing PDF full book. Access full book title Adequacy of FDA to Assure the Safety of the Nation’s Drug Supply: Congressional Hearing by . Download full books in PDF and EPUB format.
Author:
Publisher: DIANE Publishing
ISBN: 9781422320051
Category :
Languages : en
Pages : 326
Get Book Here
Book Description
Author:
Publisher: DIANE Publishing
ISBN: 9781422320051
Category :
Languages : en
Pages : 326
Get Book Here
Book Description
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 324
Get Book Here
Book Description
Author: United States. Congress. Senate. Committee on the Judiciary
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 294
Get Book Here
Book Description
Author: Food and Drug Administration
Publisher:
ISBN: 9780865879737
Category : Drugs
Languages : en
Pages : 0
Get Book Here
Book Description
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309163587
Category : Medical
Languages : en
Pages : 589
Get Book Here
Book Description
Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Author: United States. Congress. Senate. Special Committee on Aging
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 240
Get Book Here
Book Description
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309037468
Category : Medical
Languages : en
Pages : 288
Get Book Here
Book Description
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.
Author: United States. Congress. House. Committee on Energy and Commerce
Publisher:
ISBN:
Category :
Languages : en
Pages : 312
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: Thomas O. McGarity
Publisher: Yale University Press
ISBN: 0300195214
Category : Political Science
Languages : en
Pages : 519
Get Book Here
Book Description
DIV How much economic freedom is a good thing? This book tells the story of how the business community, and the trade associations and think tanks that it created, launched three powerful assaults during the last quarter of the twentieth century on the federal regulatory system and the state civil justice system to accomplish a revival of the laissez faire political economy that dominated Gilded Age America. Although the consequences of these assaults became painfully apparent in a confluence of crises during the early twenty-first century, the patch-and-repair fixes that Congress and the Obama administration put into place did little to change the underlying laissez faire ideology and practice that continues to dominate the American political economy. In anticipation of the next confluence of crises, Thomas McGarity offers suggestions for more comprehensive governmental protections for consumers, workers, and the environment. /div
