Health / Medical Topics

    Presubmission Accelerated Non-Launch Material

    Promotional materials intended to be used after the 120 day post-approval period that are submitted to FDA prior to dissemination/publication as required by 21 CFR 314.550 and 601.45. (Food and Drug Administration)




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    Promotional materials intended to be used in the first 120 days after approval that are submitted to FDA prior to dissemination/publication as…
    A process that fills a dosage unit with a pressurized liquid, which is not performed under sterile conditions.
    Flexible tubing designed to withstand high pressure.
    Pressure sores are areas of damaged skin caused by staying in one position for too long. They commonly form where your bones…
    Death of tissue due to external pressure.
    A device designed to monitor or display a pressure reading.

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