FDA in the Twenty-First Century: The Challenges of Regulating

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

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.
Country USA
Brand Columbia University Press
Manufacturer Columbia University Press
Binding Hardcover
ItemPartNumber 9780231171182
UnitCount 1
EANs 9780231171182
ReleaseDate 0000-00-00

Country	USA
Brand	Columbia University Press
Manufacturer	Columbia University Press
Binding	Hardcover
ItemPartNumber	9780231171182
UnitCount	1
EANs	9780231171182
ReleaseDate	0000-00-00

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

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