Regulatory Open Forum

 View Only

post-marketing submissions solution

  • 1.  post-marketing submissions solution

    Posted 21-Jul-2020 11:10
    Hello,
    Can I submit periodic safety reports to FDA using the regular eCTD submission tool (like docubridge etc.)?
    If we cannot and there is a separate solution for this type of submissions, could you please guide me on what to look for?
    Thank you for your time.

    Product: Drug
    Region: USA

    ------------------------------
    Artur Shchukin RAC, MS, ASQ-CQA
    Manager, RA/QA
    New York NY
    United States
    ------------------------------