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    Complete Response & Clinical Review – NDA/BLA Drugs (Ataluren 2016, Bulevirtide 2022, Roxadustat 2021, Gefapixant 2023)

    Complete Response & Clinical Review – NDA/BLA Drugs (Ataluren 2016, Bulevirtide 2022, Roxadustat 2021, Gefapixant 2023)

    $89.00 USD
    $89.00 USD
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    Request Contents: Complete response letters and clinical review reports for NDA/BLA drugs (not available in Drug@FDA database): Ataluren (2016) Bulevirtide (2022) Roxadustat (2021) Gefapixant (2023)
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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