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

Synopsis

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.

Copyright:

2015

Book Details

Book Quality:

Publisher Quality

Book Size:

568 Pages

ISBN-13:

9780231540070

Related ISBNs:

9780231171182

Publisher:

Columbia University Press

Date of Addition:

03/24/21

Copyrighted By:

Columbia University Press

Adult content:

No

Language:

English

Has Image Descriptions:

No

Categories:

Nonfiction, Science, Health, Mind and Body, Business and Finance, Law, Legal Issues and Ethics, Medicine, Politics and Government

Submitted By:

Bookshare Staff

Usage Restrictions:

This is a copyrighted book.

Edited by:

Holly Fernandez Lynch

Edited by:

I. Glenn Cohen