[evanrich]

Does the FDA have to approve it for American NGOs to distribute it internationally? Definitely would make more of a difference to African and India

[pkaye]

No it only requires the approval of the destination country. But in the case of Ebola, some of those countries didn't have an established infrastructure to run trials so the WHO initially hesitated. But in the end they got Merck to run the trials and FDA and EMA to evaluate the results.

https://www.statnews.com/2020/01/07/inside-story-scientists-...

[Vecr]

I don't think so, especially if it's nominally part of a trial. US Ebola drugs and vaccines were used in Africa before approval.