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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


Looking After the Orphans? Treatments for Rare Diseases, EU Law, and the Ethics of Costly Health Care

Keith Syrett

in European Law and New Health Technologies

Published in print:
2013
Published Online:
May 2013
ISBN:
9780199659210
eISBN:
9780191748165
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199659210.003.0006
Subject:
Law, EU Law, Medical Law

An ‘orphan drug’ technology may be defined as one which is developed for treating a rare medical condition. This chapter analyzes how the policy problem presented by orphan drug technologies has been ... More


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