Abstract
The American Orphan Drug Act has spurred international activities on orphan disease research and orphan drug research and development (R&D). Legislation has been enacted in Singapore and Japan, and is pending in Europe. Rare disease research facilities and information centers are operational in Scandinavia and Europe, facilitating the needs of patients, families, and medical personnel. Yet, the absence of a harmonized international orphan drug development program still hinders the wise use of economic and human resources in the most optimal and efficient manner.
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