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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
    Marie assists international clients in the design and implementation of global product development plans and associated regulatory strategy, in particular in the area of rare diseases. She is involved in the development of biotech products, new chemical entities, cell and gene therapy medicinal products and repurposed drugs.
    Pauline Messina thumbnail
    Pauline Messina
    Regulatory Scientist Drugs and Biologics
    Pauline is involved in different regulatory projects, conducting research and scientific writing in the framework of the design and implementation of Regulatory Strategies for the development of drugs and biologics. She also participates to lifecycle management and Marketing Authorization Application activities, including the setting of regulatory strategy, preparation of variation application dossiers, and review of product information.