FDA in the Twenty-First Century - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook FDA in the Twenty-First Century write by Holly Fernandez Lynch. This book was released on 2015-09-08. FDA in the Twenty-First Century available in PDF, EPUB and Kindle. 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.
The Proper Role of the Fda for the 21st Century
The Proper Role of the Fda for the 21st Century - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook The Proper Role of the Fda for the 21st Century write by Jason Briggeman. This book was released on 2018. The Proper Role of the Fda for the 21st Century available in PDF, EPUB and Kindle. 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
Building a 21st Century FDA - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Building a 21st Century FDA write by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. This book was released on 2007. Building a 21st Century FDA available in PDF, EPUB and Kindle.
Introduction to
Introduction to - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Introduction to write by Holly Fernandez Lynch. This book was released on 2015. Introduction to available in PDF, EPUB and Kindle. 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.
Reputation and Power
Reputation and Power - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Reputation and Power write by Daniel Carpenter. This book was released on 2014-04-24. Reputation and Power available in PDF, EPUB and Kindle. How the FDA became the world's most powerful regulatory agency The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints. Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today. Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested. Some images inside the book are unavailable due to digital copyright restrictions.
