FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

8 septembre 2015|
FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies de Holly Fernandez Lynch
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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.

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 Ca...
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Titre :FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies
Format :Couverture rigide
Dimensions de l'article :568 pages, 9 X 6 X 0 po
Dimensions à l'expédition :568 pages, 9 X 6 X 0 po
Publié le :8 septembre 2015
Publié par :Columbia University Press
Langue :anglais
Convient aux âges :Tous les âges
ISBN - 13 :9780231171182

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