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In doing so, Makary and Prasad are effectively challenging the so-called “two-study dogma” – the principle dating back to the 1960s that two independent pivotal trials are required to demonstrate safety and efficacy. The aim was to reduce the risk of chance findings. “You have to be lucky twice,” as they put it in The New England Journal of Medicine.
FDA leaders seek to scrap two-study requirement
A single pivotal study may be sufficient to secure approval for a new medicine in the United States. That is the message delivered by FDA Commissioner Marty Makary and the agency’s medical and scientific chief, Vinay Prasad, in an article in the New England Journal of Medicine.
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