We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
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.
To View This Article:
Login
Subscribe To International Pharmaceutical Regulatory Monitor