How did Vertex win an FDA approval without running a clinical trial?

Stat News

19 May 2017 - Vertex Pharmaceuticals scored a minor coup this week when the Food and Drug Administration signed off on a wider use of its banner drug for cystic fibrosis. 

But the decision wasn’t based on a large, rigorous clinical trial — or any study involving humans at all. Instead, the FDA took the word of a test tube.

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Michael Wonder

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Michael Wonder