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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.


Love and Other Technologies

Dominic Pettman

in Love and Other Technologies: Retrofitting Eros for the Information Age

Published in print:
2006
Published Online:
March 2011
ISBN:
9780823226689
eISBN:
9780823235407
Item type:
chapter
Publisher:
Fordham University Press
DOI:
10.5422/fso/9780823226689.003.0002
Subject:
Philosophy, General

This portion indicates the salient terms and conceptual frameworks required for the integration of eros, technics, and communitas. Technology, on the one hand, is not only ... More


“How Was It For Me?” Not-Seeing the Non-Spaces of Pornography

Dominic Pettman

in Love and Other Technologies: Retrofitting Eros for the Information Age

Published in print:
2006
Published Online:
March 2011
ISBN:
9780823226689
eISBN:
9780823235407
Item type:
chapter
Publisher:
Fordham University Press
DOI:
10.5422/fso/9780823226689.003.0006
Subject:
Philosophy, General

“Mainstream” pornography constitutes the basic tension in “whateverbeing” such that lust is being equated to feelings of affection or, perhaps, that the completeness of the ... More


Zero-Sum Matrix Games

João P. Hespanha

in Noncooperative Game Theory: An Introduction for Engineers and Computer Scientists

Published in print:
2017
Published Online:
May 2018
ISBN:
9780691175218
eISBN:
9781400885442
Item type:
chapter
Publisher:
Princeton University Press
DOI:
10.23943/princeton/9780691175218.003.0003
Subject:
Mathematics, Logic / Computer Science / Mathematical Philosophy

This chapter discusses a number of key concepts for zero-sum matrix games. A zero-sum matrix game is played by two players, each with a finite set of actions. Player 1 wants to minimize the outcome ... More


Two-Player Non-Zero-Sum Games

João P. Hespanha

in Noncooperative Game Theory: An Introduction for Engineers and Computer Scientists

Published in print:
2017
Published Online:
May 2018
ISBN:
9780691175218
eISBN:
9781400885442
Item type:
chapter
Publisher:
Princeton University Press
DOI:
10.23943/princeton/9780691175218.003.0009
Subject:
Mathematics, Logic / Computer Science / Mathematical Philosophy

This chapter defines a number of key concepts for non-zero-sum games involving two players. It begins by considering a two-player game G in which two players P₁ and P₂ are allowed to select policies ... More


Fungible Geographies

Swati Chattopadhyay

in Unlearning the City: Infrastructure in a New Optical Field

Published in print:
2012
Published Online:
August 2015
ISBN:
9780816679317
eISBN:
9781452947266
Item type:
chapter
Publisher:
University of Minnesota Press
DOI:
10.5749/minnesota/9780816679317.003.0007
Subject:
Architecture, Architectural Theory and Criticism

This chapter discusses the occupation of public space by the pandals, or temporary pavilions for festivities, becoming an important reference in the debates over legitimate use of public space and ... More


Executive Agreements

Curtis A. Bradley

in International Law in the U.S. Legal System

Published in print:
2015
Published Online:
April 2015
ISBN:
9780190217761
eISBN:
9780190217808
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780190217761.003.0003
Subject:
Law, Private International Law, Comparative Law

This chapter considers the status in the U.S. legal system of “executive agreements”—that is, international agreements concluded by the United States outside of the senatorial advice and consent ... More


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