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Obtaining Orphan Status – A key milestone within a development strategy

Post thumbnail Obtaining Orphan Status – A key milestone within a development strategy

This article describes the regulatory frameworks and incentives associated with orphan drug designation (ODD) in the EU and the US, as well as capturing key strategic considerations needed to achieve successful orphan drug product development and registration in both regions.

 

Published on: July, 2021
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    publication by

    Marie Deneux thumbnail
    Marie Deneux
    Senior Director Regulatory Science Drugs & Biologics
    Pauline Messina thumbnail
    Pauline Messina
    Regulatory Scientist Drugs and Biologics