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Posted On: 03/20/2017 1:19:23 PM
Post# of 15624
For those that really want to get in deep with test results and how they can be submitted to the FDA AND approved, here's the guide.
FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND
https://www.fda.gov/downloads/RegulatoryInfor...294729.pdf
So the supposition that Israel results of the safety trials can be used and approved by the FDA saving both time and money aren't that far off. Guessing that's why they expanded the trial to begin with.
FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND
https://www.fda.gov/downloads/RegulatoryInfor...294729.pdf
So the supposition that Israel results of the safety trials can be used and approved by the FDA saving both time and money aren't that far off. Guessing that's why they expanded the trial to begin with.
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