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From “Recycled Molecule” to Orphan Drug: Lessons from Makena

Kate Greenwood

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/9780231171182.003.0026
Subject:
Law, Medical Law

In 2011, the Food and Drug Administration made the controversial decision not to enforce the Orphan Drug Act’s period of market exclusivity for Makena (hydroxyprogesterone caproate injection), ... More


Sea Monsters, Immunauts, and Death Panels

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/9781469630625.003.0009
Subject:
Business and Management, Innovation

We return to the rise of biotechnology, revealing the risks and rewards arising from recombinant DNA technologies as evidenced by the formation and ultimate dissolution of the first biotechnology ... More


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