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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Original Message:
Sent: 05-Jun-2023 12:11
From: Devender Sandhu
Subject: UK clinical trial data ( Phase 1 to 3) acceptance im USA
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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