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Top FDA officials said that a single pivotal trial requirement will be the “new default standard” for drug approvals, a move that goes beyond the agency’s prior discretion around not requiring two trials.
In a “Sounding Board” published Wednesday evening in the New England Journal of Medicine, FDA Commissioner Marty Makary and vaccines chief Vinay Prasad explain that two trials can reduce false-positive conclusions. But, they write, “as drug discovery becomes increasingly precise and scientific,” an “overreliance on two trials no longer makes sense.”
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