All Orphan drug designation (ODD) articles
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Journal
Navigating orphan drug designation in the EU
Orphan drug designation (ODD) is granted to help with the development of treatement for rare diseases. In this article, ODD’s legal framework and its benefits and challenges are explored.
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Editorial
Advanced therapies: A maturing regulatory framework
This issue looks at CMC requirements, recent therapeutic innovations in the oncology field, and the complex interconnection between ATMPs and in vitro diagnostic medical devices.
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