So I’m American and was wondering how we come to accept drugs that have passed trials in other countries but have not started theirs in ours. Is there always a need for them to start trials here? If it passes elsewhere does that mark them down as acceptable practice/use here?
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The FDA has processes for considering trials performed elsewhere. In fact, [a document detailing their requirements for such cases](https://www.fda.gov/media/83209/download) is the first thing that comes up when you google “FDA clinical trials performed elsewhere”.
Whether a drug passes a trial is ultimately for local authorities to decide, and if those authorities are generally trustworthy (i.e. the European Union’s EMA) it will probably factor into FDA decision making, but approval by one country’s regulators isn’t a guarantee for approval by any other country’s regulators.
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