Home » Final U.S. Orphan Drug Rules Clarify ‘Orphan Subset,’ ‘Clinical Superiority’
Final U.S. Orphan Drug Rules Clarify ‘Orphan Subset,’ ‘Clinical Superiority’
July 10, 2013
The U.S. Food and Drug Administration has finalized changes to orphan drug regulations, clarifying confusion around orphan drug designation and the terms that have hung up sponsors of rare-disease treatments.
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