Regulatory Open Forum

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  • 1.  Medical Gas Certification

    Posted 22-Mar-2017 08:47
    Dear All,

    Is anyone aware of any company who submitted an NDA for medical gas certification? 

    I am wondering if there is any medical gas certification granted for indications other than those covered by the FDCA. 

    Currently we have our Type B Meeting scheduled.  

    Thanks!  David