FDA in the Twenty-First Century

FDA in the Twenty-First Century
Author: Holly Fernandez Lynch
Publisher: Columbia University Press
Total Pages: 499
Release: 2015-09-08
Genre: Business & Economics
ISBN: 0231540078

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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.

Introduction to

Introduction to
Author: Holly Fernandez Lynch
Publisher:
Total Pages: 0
Release: 2015
Genre:
ISBN:

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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. This paper is the introduction to a book of 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. It discusses 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. It 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, contributors rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions in other countries.

Building a 21st Century FDA

Building a 21st Century FDA
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
Total Pages: 106
Release: 2007
Genre: Medical
ISBN:

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The Proper Role of the Fda for the 21st Century

The Proper Role of the Fda for the 21st Century
Author: Jason Briggeman
Publisher:
Total Pages: 38
Release: 2018
Genre:
ISBN:

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The FDAņs mission is to permit safe and effective new drugs, biologics, and devices onto the market in an efficient and timely manner. But fear of being blamed for the failings of approved products has caused the FDA to become too restrictive. The FDA has strayed from the safety and effectiveness standards that are set out in the law, instead applying standards for approval that are based on predicting the benefits and risksᔜlinical utility, disease outcomes, survivalőthat an ᑺverage patientň will experience. But these outcomes are better evaluated in real-world, post-market settingsőthat is, in the medical marketplace, where knowledge about the value of a drug or device for different types of patients can grow over time. The FDA must return to its role as gatekeeper of safe and effective drugs and devices, and refrain from attempting to anticipate the future judgments of physicians and patients regarding benefits and risks.

Building A 21st Century FDA: Proposals to Improve Drug Safety and Innovation HRG 109-850

Building A 21st Century FDA: Proposals to Improve Drug Safety and Innovation HRG 109-850
Author: Various
Publisher: Legare Street Press
Total Pages: 0
Release: 2022-10-27
Genre: Literary Collections
ISBN: 9781017873573

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This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work is in the "public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.

Building a 21st Century FDA

Building a 21st Century FDA
Author: United States Senate
Publisher:
Total Pages: 104
Release: 2019-12-17
Genre:
ISBN: 9781675771693

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Building a 21st century FDA: proposals to improve drug safety and innovation: hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, second session, on examining proposals to improve drug safety and innovation, and S. 3807, to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug s

Building a 21st Century FDA

Building a 21st Century FDA
Author: Various
Publisher: Pinnacle Press
Total Pages: 104
Release: 2017-05-25
Genre: Literary Collections
ISBN: 9781374919723

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This work has been selected by scholars as being culturally important and is part of the knowledge base of civilization as we know it. This work is in the public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. To ensure a quality reading experience, this work has been proofread and republished using a format that seamlessly blends the original graphical elements with text in an easy-to-read typeface. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.

Building a 21st Century FDA

Building a 21st Century FDA
Author: Various
Publisher: Scholar's Choice
Total Pages: 106
Release: 2015-02-16
Genre:
ISBN: 9781298059529

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This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work was reproduced from the original artifact, and remains as true to the original work as possible. Therefore, you will see the original copyright references, library stamps (as most of these works have been housed in our most important libraries around the world), and other notations in the work. This work is in the public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work.As a reproduction of a historical artifact, this work may contain missing or blurred pages, poor pictures, errant marks, etc. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.

The Poison Squad

The Poison Squad
Author: Deborah Blum
Publisher: Penguin
Total Pages: 370
Release: 2018-09-25
Genre: Political Science
ISBN: 0525560289

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A New York Times Notable Book The inspiration for PBS's AMERICAN EXPERIENCE film The Poison Squad. From Pulitzer Prize winner and New York Times-bestselling author Deborah Blum, the dramatic true story of how food was made safe in the United States and the heroes, led by the inimitable Dr. Harvey Washington Wiley, who fought for change By the end of nineteenth century, food was dangerous. Lethal, even. "Milk" might contain formaldehyde, most often used to embalm corpses. Decaying meat was preserved with both salicylic acid, a pharmaceutical chemical, and borax, a compound first identified as a cleaning product. This was not by accident; food manufacturers had rushed to embrace the rise of industrial chemistry, and were knowingly selling harmful products. Unchecked by government regulation, basic safety, or even labelling requirements, they put profit before the health of their customers. By some estimates, in New York City alone, thousands of children were killed by "embalmed milk" every year. Citizens--activists, journalists, scientists, and women's groups--began agitating for change. But even as protective measures were enacted in Europe, American corporations blocked even modest regulations. Then, in 1883, Dr. Harvey Washington Wiley, a chemistry professor from Purdue University, was named chief chemist of the agriculture department, and the agency began methodically investigating food and drink fraud, even conducting shocking human tests on groups of young men who came to be known as, "The Poison Squad." Over the next thirty years, a titanic struggle took place, with the courageous and fascinating Dr. Wiley campaigning indefatigably for food safety and consumer protection. Together with a gallant cast, including the muckraking reporter Upton Sinclair, whose fiction revealed the horrific truth about the Chicago stockyards; Fannie Farmer, then the most famous cookbook author in the country; and Henry J. Heinz, one of the few food producers who actively advocated for pure food, Dr. Wiley changed history. When the landmark 1906 Food and Drug Act was finally passed, it was known across the land, as "Dr. Wiley's Law." Blum brings to life this timeless and hugely satisfying "David and Goliath" tale with righteous verve and style, driving home the moral imperative of confronting corporate greed and government corruption with a bracing clarity, which speaks resoundingly to the enormous social and political challenges we face today.