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Re: loanranger post# 253735

Wednesday, 01/09/2019 11:34:42 AM

Wednesday, January 09, 2019 11:34:42 AM

Post# of 403033
"A Phase 3 trial in Europe wouldn't act to secure FDA approval for distribution in the US, would it?"

Yes it would, as long as the trial is run according to FDA approved protocol and FDA is able to validate trial data with onsite inspections. The reverse is generally true for EMA approval of a drug based on a trial run in US. FDA has even granted initial approvals based solely on trial(s) conducted outside US. Votrient (pazopanib) is one of those drugs.

Readable overview about FDA's expectations for acceptable IND and non-IND trials conducted outside USA.
https://www.fda.gov/downloads/drugs/newsevents/ucm441250.pdf


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