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Prescription for Change: The Looming Crisis in Drug Development

Michael Kinch

Published in print:
2016
Published Online:
May 2017
ISBN:
9781469630625
eISBN:
9781469630649
Item type:
book
Publisher:
University of North Carolina Press
DOI:
10.5149/northcarolina/9781469630625.001.0001
Subject:
Business and Management, Innovation

The introduction of new medicines has dramatically improved the quantity and quality of individual and public health while contributing trillions of dollars to the global economy. In spite of these ... More


Managing Culture

Veronica Hope Hailey

in Strategic Human Resource Management: Corporate Rhetoric and Human Reality

Published in print:
1999
Published Online:
October 2011
ISBN:
9780198782049
eISBN:
9780191695421
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780198782049.003.0005
Subject:
Business and Management, HRM / IR, Strategy

This chapter describes the different approaches taken by two companies (Glaxo Pharmaceuticals UK and Hewlett Packard) to managing culture. Despite the difference in approach, both organizations ... More


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

Holly Fernandez Lynch and I. Glenn Cohen (eds)

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
book
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.001.0001
Subject:
Law, Medical Law

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 ... More


After the FDA: A Twentieth-Century Agency in a Postmodern World

Theodore W. Ruger

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0006
Subject:
Law, Medical Law

The FDA over the past century has achieved high levels of regulatory prestige by enforcing statutory standards of safety and efficacy with relatively little regulation of the end-stage use, or the ... More


FDA, Negotiated Rulemaking, and Generics: A Proposal

Marie Boyd

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0027
Subject:
Law, Medical Law

Recent U.S. Supreme Court holdings suggest that while the manufacturer of a brand-name drug is always responsible for its label’s content, this is not the case for generic drugs. In addition, these ... More


South-South Cooperation in Biotechnology: Medicine for the Masses

John M. Kirk

in Healthcare Without Borders: Understanding Cuban Medical Internationalism

Published in print:
2015
Published Online:
May 2016
ISBN:
9780813061054
eISBN:
9780813051338
Item type:
chapter
Publisher:
University Press of Florida
DOI:
10.5744/florida/9780813061054.003.0007
Subject:
Society and Culture, Latin American Studies

Cuba produces the majority of its own medicines, and exports pharmaceuticals around the world—mainly to developing countries. This chapter examines the origins of Cuban biotechnology, its basic ... More


Autophagy

Michael Kinch

in Prescription for Change: The Looming Crisis in Drug Development

Published in print:
2016
Published Online:
May 2017
ISBN:
9781469630625
eISBN:
9781469630649
Item type:
chapter
Publisher:
University of North Carolina Press
DOI:
10.5149/northcarolina/9781469630625.003.0011
Subject:
Business and Management, Innovation

The title of the chapter is a Greek term that literally translates into “eating oneself” and is representative of a trend of mergers and acquisitions that has subsumed the drug development enterprise ... More


The Government and the Private Market in Health Care

Robert I. Field

in Mother of Invention: How the Government Created "Free-Market" Health Care

Published in print:
2013
Published Online:
January 2014
ISBN:
9780199746750
eISBN:
9780199354528
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199746750.003.0002
Subject:
Public Health and Epidemiology, Public Health

The American health care system, which appears on its surface as a predominantly private endeavour, actually rests on a foundation of government support. Itreflects a huge public-private partnership ... More


FastXFast

Mike Fortun

in Promising Genomics: Iceland and deCODE Genetics in a World of Speculation

Published in print:
2008
Published Online:
March 2012
ISBN:
9780520247505
eISBN:
9780520942615
Item type:
chapter
Publisher:
University of California Press
DOI:
10.1525/california/9780520247505.003.0003
Subject:
Biology, Evolutionary Biology / Genetics

This chapter discusses how speed genomics spurred a complex political economy in Iceland, focusing on the experiences of three of the earliest genomics-based companies: Human Genome Sciences Inc., ... More


Bitter Roots: The Search for Healing Plants in Africa

Abena Dove Osseo-Asare

Published in print:
2014
Published Online:
May 2014
ISBN:
9780226085524
eISBN:
9780226086163
Item type:
book
Publisher:
University of Chicago Press
DOI:
10.7208/chicago/9780226086163.001.0001
Subject:
History, History of Science, Technology, and Medicine

Bitter Roots is a history of drug discovery from plants across different African countries. It reconsiders the history of pharmaceutical patents, biopiracy, and bioprospecting to show that African ... More


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