Regulatory Open Forum

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  • 1.  UK clinical trial data ( Phase 1 to 3) acceptance im USA

    Posted 05-Jun-2023 12:11

    If  clinical trials have been successfully complete for a vaccine in UK or EU and may get affirmative approval  then can that UK/EU generated clinical data can be accepted in USA for approvals or additional clinical studies will be required in for US Application. 



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    Devender Sandhu
    Director
    Thornhill ON
    Canada
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  • 2.  RE: UK clinical trial data ( Phase 1 to 3) acceptance im USA

    Posted 05-Jun-2023 15:00

    On paper or from regulatory perspective yes, foreign generated clinical trial data are accepted for approval in the US. However, from the FDA perspective if the data is inadequate in some parts of the entire clinical/non-clinical development then one needs to address those deficiencies. The first thing I'd do is to schedule a FDA meeting (type b) to assess the adequacy of your data to support approval in the US.



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    GRSAOnline
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