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FDA Regulation of Biosimilars

Henry Grabowski and Erika Lietzan

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/9780231171182.003.0029
Subject:
Law, Medical Law

The FDA requirements for products to be approved as a biosimilar to a reference biological drug product will have a profound impact on market entry, competition and cost savings to consumers.


Cinema and Prison Reform

Alison Griffiths

in Carceral Fantasies: Cinema and Prison in Early Twentieth-Century America

Published in print:
2016
Published Online:
January 2017
ISBN:
9780231161060
eISBN:
9780231541565
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231161060.003.0007
Subject:
Film, Television and Radio, Film

Chapter 6: “Cinema and Prison Reform” examines how penal reformers appropriated cinema for their cause, addressing not only the moral rehabilitation of individual prisoners, but also changes in ... More


The End of Selfishness

August Turak

in Business Secrets of the Trappist Monks: One CEO's Quest for Meaning and Authenticity

Published in print:
2013
Published Online:
November 2015
ISBN:
9780231160629
eISBN:
9780231535229
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231160629.003.0003
Subject:
Business and Management, Business Ethics and Corporate Social Responsibility

This chapter explains how a permanent transformation of being from selfishness to selflessness translates to business success as demonstrated by the Trappist monks of Mepkin Abbey. According to Louis ... More


The Power of Trust

August Turak

in Business Secrets of the Trappist Monks: One CEO's Quest for Meaning and Authenticity

Published in print:
2013
Published Online:
November 2015
ISBN:
9780231160629
eISBN:
9780231535229
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231160629.003.0010
Subject:
Business and Management, Business Ethics and Corporate Social Responsibility

This chapter explains how trust contributes to business success by highlighting the case of the Trappist monks of Mepkin Abbey. It argues that the success of every CEO depends far more on vendors, ... More


Self-Knowledge and Authenticity

August Turak

in Business Secrets of the Trappist Monks: One CEO's Quest for Meaning and Authenticity

Published in print:
2013
Published Online:
November 2015
ISBN:
9780231160629
eISBN:
9780231535229
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231160629.003.0011
Subject:
Business and Management, Business Ethics and Corporate Social Responsibility

This chapter discusses the importance of self-knowledge and authenticity in achieving business success as exemplified by the Trappist monks of Mepkin Abbey. All religious traditions consider ... More


The Use of Investment Incentives: The Cases of R&D-Related Incentives and International Investment Agreements

Christian Bellak and Markus Leibrecht

in Rethinking Investment Incentives: Trends and Policy Options

Published in print:
2016
Published Online:
January 2017
ISBN:
9780231172981
eISBN:
9780231541640
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231172981.003.0004
Subject:
Economics and Finance, Financial Economics

The chapter gives an in-depth look at two types of investment incentives used globally: International investment agreements (IIAs) as broadly available regulatory “incentives” to attract FDI and ... More


Incentives in the European Union

Philippe Gugler

in Rethinking Investment Incentives: Trends and Policy Options

Published in print:
2016
Published Online:
January 2017
ISBN:
9780231172981
eISBN:
9780231541640
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231172981.003.0005
Subject:
Economics and Finance, Financial Economics

This Chapter looks at how the European Union and its individual member states are using incentives as one strategy to strengthen the attractiveness for FDI. Importantly, Gugler also describes in ... More


Politics of Healing

John S. Haller

in Shadow Medicine: The Placebo in Conventional and Alternative Therapies

Published in print:
2014
Published Online:
November 2015
ISBN:
9780231169042
eISBN:
9780231537704
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231169042.003.0004
Subject:
Public Health and Epidemiology, Public Health

This chapter describes the political pressures that led to the creation of the Office for the Study of Unconventional Medical Practices. The exponential growth for medical costs starting in the 1970s ... More


Marxism and the West

Enzo Traverso

in Left-Wing Melancholia: Marxism, History, and Memory

Published in print:
2017
Published Online:
January 2019
ISBN:
9780231179423
eISBN:
9780231543019
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231179423.003.0006
Subject:
Political Science, Political Theory

The fifth chapter starts by describing the Marxist vision of the West as world’s destiny, according to a Eurocentric conception of history inherited from Hegel. Then, it analyzes the missed dialogue ... More


Expectations Before the Rational Expectations Revolution

Eric Barthalon

in Uncertainty, Expectations, and Financial Instability: Reviving Allais's Lost Theory of Psychological Time

Published in print:
2014
Published Online:
November 2015
ISBN:
9780231166287
eISBN:
9780231538305
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231166287.003.0001
Subject:
Economics and Finance, Behavioural Economics

This chapter reviews a number of expectations theories that preceded the rational expectations hypothesis (REH). It first considers R. Cantillon's views on the role of expectations in economics, ... More


Getting Into Orbit

James Clay Moltz

in Crowded Orbits: Conflict and Cooperation in Space

Published in print:
2014
Published Online:
November 2015
ISBN:
9780231159128
eISBN:
9780231528177
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231159128.003.0001
Subject:
Political Science, Conflict Politics and Policy

This chapter explores the development of the technologies required for spaceflight. Getting into space involves understanding the basic physics of propulsion and mastering a specific type of ... More


Missing the Boat 1945–1964

Robert McCaughey

in A Lever Long Enough: A History of Columbia's School of Engineering and Applied Science Since 1864

Published in print:
2014
Published Online:
November 2015
ISBN:
9780231166881
eISBN:
9780231537520
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231166881.003.0005
Subject:
History, American History: 20th Century

This chapter reviews developments at Columbia University's School of Engineering and Applied Science (SEAS) during the years 1945–1964. It first considers the leadership vacuum at SEAS in the ... More


The Depressed Classes, Rights, and the Embrace of the Social

Rupa Viswanath

in The Pariah Problem: Caste, Religion, and the Social in Modern India

Published in print:
2014
Published Online:
November 2015
ISBN:
9780231163064
eISBN:
9780231537506
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231163064.003.0009
Subject:
History, Indian History

This chapter discusses the contribution of Dalit representatives in solving the Pariah Problem. Beginning in 1918, Dalit representatives—L. C. Guruswami, M. C. Rajah, Rettamalai Srinivasan, and R. ... More


Super Thief

Michael F. Armstrong

in They Wished They Were Honest: The Knapp Commission and New York City Police Corruption

Published in print:
2012
Published Online:
November 2015
ISBN:
9780231153546
eISBN:
9780231526982
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231153546.003.0013
Subject:
History, American History: 20th Century

This chapter focuses on William R. Phillips, a patrolman assigned to the 25th Precinct in Harlem. Phillips was the answer to the Commission's earnest search for sufficient evidence of corruption in ... More


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