Fda Issues

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Ethical And Scientific Issues In Studying The Safety Of Approved Drugs

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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-07-30

Ethical And Scientific Issues In Studying The Safety Of Approved Drugs written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-07-30 with Medical categories.

An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.

Fda Issues

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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
language : en
Publisher:
Release Date : 1985

Fda Issues written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1985 with Milk contamination categories.

Fda Issues

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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
language : en
Publisher:
Release Date : 1985

Food And Drug Administration Fda

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Author :
language : en
Publisher:
Release Date : 2008

Food And Drug Administration Fda written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with categories.

Fda In The Twenty First Century

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Author : Holly Fernandez Lynch
language : en
Publisher: Columbia University Press
Release Date : 2015-09-08

Fda In The Twenty First Century written by Holly Fernandez Lynch and has been published by Columbia University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-09-08 with Business & Economics categories.

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

Fda Issues In The 105th Congress

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Author :
language : en
Publisher:
Release Date : 1997

Fda Issues In The 105th Congress written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with Public health laws categories.

Fda Issues

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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
language : en
Publisher:
Release Date : 1985

Advisory Committee On The Food And Drug Administration

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Author : United States. Congress. Senate. Committee on Labor and Human Resources
language : en
Publisher:
Release Date : 1992

Advisory Committee On The Food And Drug Administration written by United States. Congress. Senate. Committee on Labor and Human Resources and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Political Science categories.

The Food And Drug Administration Fda

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Author : Meredith A. Hickmann
language : en
Publisher: Nova Publishers
Release Date : 2003

The Food And Drug Administration Fda written by Meredith A. Hickmann and has been published by Nova Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with Business & Economics categories.

The FDA is responsible for ensuring the safety of foods, drugs, medical devices, cosmetics, and a variety of other products. These products account for 25 cents of every dollar US consumers spend. Under the authority of the Federal Food, Drug, and Cosmetic Act, FDA is responsible for ensuring that these products are safe, accurately labelled, and in the case of drugs and medical devices, effective. FDA's tasks include: enforcement, pre-market product evaluation and approval, post-market surveillance and investigations, publishing of regulations, conducting and monitoring of research, public education, and regulating products and processes to prevent hazards to human health. Contents: Preface; Food and Drug Administration: Selected Funding Data; Food and Drug Administration: Selected Funding and Policy Issues; US European Agricultural Trade: Food and Biotechnology Issues; Food and Drug Administration: Selected Funding and Policy Issues; Food and Drug Administration Modernisation Act of 1997 -- The Provisions; Index.

Inside The Fda

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Author : Fran Hawthorne
language : en
Publisher: John Wiley & Sons
Release Date : 2010-12-13

Inside The Fda written by Fran Hawthorne and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-13 with Business & Economics categories.

The forces that shape America's most powerful consumer agency Because of the importance of what it regulates, the FDA comes under tremendous political, industry, and consumer pressure. But the pressure goes far beyond the ordinary lobbying of Washington trade groups. Its mandate-one quarter of the national economy-brings the FDA into the middle of some of the most important and contentious issues of modern society. From "designer" babies and abortion to the price of prescription drugs and the role of government itself, Inside the FDA takes readers on an intriguing journey into the world of today's most powerful consumer agency. In a time when companies continue to accuse the FDA of nitpicking and needlessly delaying needed new drugs, and consumers are convinced that the agency bends to industry pressure by rushing unsafe drugs to market, Inside the FDA digs deep to reveal the truth. Through scores of interviews and real-world stories, Hawthorne also shows how and why the agency makes some of its most controversial decisions as well as how its recent reaction to certain issues-including the revolutionary cancer drug Erbitux, stem cell research, and bioengineering of food-may jeopardize its ability to keep up with future scientific developments. Inside the FDA takes a closer look at the practices, people, and politics of this crucial watchdog in light of the competing pressures and trends of modern society, revealing what the FDA is supposed to do, what it actually does-and fails to do-who it influences, and how it could better fulfill its mandate. The decisions that the FDA makes are literally life and death. Inside the FDA provides a sophisticated account of how this vitally important agency struggles to balance bureaucracy and politics with its overriding mission to promote the country's health.

Fda Issues

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