Review:
This book contains a concise historical account of FDA regulation and an insightful analysis of the major challenges the FDA faces over the next quarter century. The contributors, drawn from a variety of fields, are all authorities on the issues at hand. Although they do not share the same opinions, their disagreements make this essay collection remarkably balanced. Essential reading.--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. The book's contributors offer thoughtful and well-researched policy approaches on conundrums facing the FDA and similar agencies around the world. Bravo!--Frank Pasquale, University of Maryland, Carey School of Law
This insightful and informative book draws on a variety of perspectives to chart a course for the FDA--and society--as we confront the challenges of medical-product regulation in the twenty-first century. It should be read by regulators and the regulated alike, as well as by patients, policy makers, payers, physicians, pharmacists--anyone interested in human health.--Daniel Troy, general counsel, GlaxoSmithKline PLC, and chief counsel of the FDA from 2001 to 2004
FDA in the Twenty-First Century lives up to its title. Drawing on the historical evolution of the FDA, this book lays out, in a clear and thoughtful manner, key questions for the future. At a time when scientific opportunities are presenting at lightning speed and the expectations of the public for transparency, personalized medicine, and safety have never been greater, this is an important book.--Amy Rick, Food and Drug Law Institute
FDA in the Twenty-First Century does an excellent job of highlighting and explaining... it is a useful source for anyone interested in the nexus of modern medical bureaucracy.--Devorah Goldman "The Weekly Standard "
Essential reading for anyone who wants to understand the powerful forces driving the FDA's evolution.--Norman M. Goldfarb "Journal of Clinical Research Best Practices "
[These] essays provide an excellent survey of the growing challenges the FDA faces.... Highly recommended.--Choice
This informative book is a valuable read for lawyers, policymakers, and anyone interested in public health.--Harvard Law Review
About the Author:
Holly Fernandez Lynch is the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. She is a lawyer and bioethicist, with expertise in the ethics and regulation of human-subjects research and drug development. She is also the author of Conflicts of Conscience in Health Care: An Institutional Compromise. I. Glenn Cohen is a professor at Harvard Law School and faculty director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. He is the author of more than eighty articles and book chapters and the author, editor, or coeditor of seven books. 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.
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