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The Challenges of Orphan Drugs and Orphan Diseases: Real and Imagined
Author(s) -
Hudson I,
Breckenridge A
Publication year - 2012
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2012.72
Subject(s) - orphan drug , clinical pharmacology , incentive , legislation , pharmacology , medicine , alternative medicine , business , political science , law , economics , bioinformatics , biology , pathology , microeconomics
The Orphan Drug Act of 1983 in the United States and similar legislation in Europe in 1999 provided incentives for companies to develop and sell medicines for diseases with a small market. In this Commentary, we outline the European position on the regulation of orphan drugs and explain where it differs from the regulation in the United States. Clinical Pharmacology & Therapeutics (2012); 92 2, 151–153. doi: 10.1038/clpt.2012.72