FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies
| Author | : | |
| Rating | : | 4.83 (900 Votes) |
| Asin | : | 0231171188 |
| Format Type | : | paperback |
| Number of Pages | : | 568 Pages |
| Publish Date | : | 2015-12-07 |
| Language | : | English |
DESCRIPTION:
(Harvard Law Review) . (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. (Choice)Essential reading for anyone who wants to understand the powerful forces driving the FDA's evolution. Highly recommended. (Norman M. (Devorah Goldman The Weekly Standard)These essays provide an excellent survey of the growing challenges the FDA faces. 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. Th
Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. 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.. 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 regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry
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. Glenn Cohen is a professor at Harvard Law School and faculty director of the Petrie-Flom Center f