Skip to main content

Overview of CDER’s Real-World Evidence Demonstration Projects

    Event Information
    Date
    Time
    Time
    12:00pm - 1:00pm EST
    Event Type
    Webinar
    Event Location
    Virtual
    Description

    Aligned with the U.S. 21st Century Cures Act, FDA established a program to evaluate the potential use of real-world evidence (RWE) in regulatory decision-making. The program is multifaceted and supports activities such as demonstration (research) projects, guidance development, internal Agency processes, external stakeholder engagement, and the Advancing Real-World Evidence initiative. This talk presented an overview of several RWE demonstration projects and described, for select projects, how learnings directly or indirectly serve to support FDA regulatory decision-making in evaluating the effectiveness and safety of medical products.

    Event Materials

    View a recording of the webinar here.

    View the presentation of the webinar here.

    Information
    Host

    Sentinel Innovation Center

    Presenter(s)

    Marie C. Bradley, PhD, MPharm, MSc.PH