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Clin Pharmacol Ther. 2012 Aug;92(2):151-3. doi: 10.1038/clpt.2012.72.

The challenges of orphan drugs and orphan diseases: real and imagined.

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  • 1Medicines and Healthcare Products Regulatory Agency, London, UK.


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.

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