Regulatory Open Forum

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  • 1.  Scope of essential device / drug

    Posted 09-Aug-2020 18:47
    ​​Hi RAPS members,

    Last friday, President Trump signed an executive order which targets essential drugs and devices. 
    Does any one know scope of essential drugs and devices? which drugs and devices are falls in the scope of essential drugs and devices?

    Related news is below.
    https://www.raps.org/news-and-articles/news-articles/2020/8/trumps-buy-american-order-tasks-fda-on-essential-d?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%207%20August%202020

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    Jeongpyo Hong
    Sr. Professional, Regulatory Affairs
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  • 2.  RE: Scope of essential device / drug

    Posted 10-Aug-2020 02:01
    Hi Jeongpyo,

    The FDA will develop an initial list of essential medicines, medical countermeasures and critical inputs in 30 days and finalise the list in 90 days.

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    Michelle Knight
    Clinical and Regulatory Manager
    Coburg VIC
    Australia
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