FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies
Author | : | |
Rating | : | 4.50 (601 Votes) |
Asin | : | 0231171188 |
Format Type | : | paperback |
Number of Pages | : | 568 Pages |
Publish Date | : | 2017-12-31 |
Language | : | English |
DESCRIPTION:
(Anup Malani, University of Chicago)A truly magisterial collection, FDA in the Twenty-First Century is a must-read for academics, practitioners, and social scientists interested in the future of drug and device regulation. Essential reading. (Norman M. Although they do not share the same opinions, their disagreements make this essay collection remarkably balanced. It should be read by regulators and the regulated alike, as well as by patients, policy makers, payers, physicians, pharmacistsanyone interested in human health. The contributors, drawn from a variety of fields, are all authorities on the issues at hand. Drawing on the historical evolution of the FDA, this book lays out, in
She is a lawyer and bioethicist, with expertise in the ethics and regulation of human-subjects research and drug development. In addition to the ethics and regulation of drug development, he works on reproductive technologies, medical tourism, rationing, the bioethics of professional sports, and other topics. He is the author of more than eigh
Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. 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.. 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. 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