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    FDA: FDA eCTD Submissions - Regulatory Review & Approvals (2022-2023)

    FDA: FDA eCTD Submissions - Regulatory Review & Approvals (2022-2023)

    $89.00 USD
    $89.00 USD
    Sale Sold out
    Request Content: Regulatory Review and approval of eCTD submissions, including: Quality Removal of in-process blend uniformity (Approved 3/08/2022) sNDA PBPK Dosing and administration USPI (Approved 9/08/2023)
    • 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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